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• applications(array)
  • 0(array)
    • Application(array)
      • id351
      • user_id77
      • trial_status_id5
      • abstract_of_study<div>\n DESIGN A5297 is a phase I/II, open-label, proof of concept, two-step, two-arm, controlled randomized clinical trial (RCT) to test the superiority of lopinavir/ritonavir (LPV/r)-based antiretroviral therapy (ART) to non-nucleoside reverse transcriptase (nNRTI)-based ART for clearance of Plasmodium falciparum (Pf) subclinical parasitemia (SCP).</div>\n<div>\n Participants will be followed for 30 days in order to evaluate parasitemia clearance, Pf parasitemia, gametocytemia, and plasmepsin sequencing. Participants will have blood collected twice at entry, day 3, 6, 9, 12, 20, and 25 and three times for day 15 and day 30. Therefore, on most study days, participants will need to either remain at the clinic for an extended period of time or be willing to return two or three times at approximately 8-hour intervals (see section 6.2 for details).</div>\n<div>\n DURATION 30 days: Step 1= days 1-15; Step 2= days 16-30</div>\n<div>\n SAMPLE SIZE 52 participants</div>\n<div>\n POPULATION HIV infected adults at least 18 years of age with CD4+ counts >200 and < 350 cells/mm3 who will be starting ART and have Pf SCP. Individuals with signs or symptoms suggestive of concurrent opportunistic infections, pulmonary or gastrointestinal infections, or clinical malaria will be excluded.</div>\n<div>\n REGIMENS Step 1</div>\n<div>\n Participants will be randomized 1:1 to one of the following arms for 15 days:</div>\n<div>\n Arm A: LPV/r-based ART</div>\n<div>\n Arm B: nNRTI-based ART</div>\n<div>\n Step 2</div>\n<div>\n All participants will receive an nNRTI-based ART and TMP/SMX prophylaxis to take from day 16 through day 30.</div>\n<div>\n  </div>\n<div>\n <div>\n <div>\n 1.0 HYPOTHESES AND STUDY OBJECTIVES</div>\n <div>\n 1.1 Primary Hypothesis</div>\n <div>\n In HIV-infected participants with CD4+ counts >200 and <350 cells/mm3, lopinavir/ritonavir (LPV/r)-based ART will be superior to nNRTI-based ART in PCR-defined Plasmodium falciparum (Pf) subclinical parasitemia (SCP) clearance after 15 days of therapy.</div>\n <div>\n 1.2 Secondary Hypotheses</div>\n <div>\n 1.2.1 Pf parasite densities in participants with Pf SCP who have received 15 days (Step 1) of LPV/r-based ART will be lower than those receiving nNRTI-based ART.</div>\n <div>\n 1.2.2 Time to clearance in participants with Pf SCP will be shorter in participants who have received 15 days (Step 1) of LPV/r-based ART compared with those receiving nNRTI-based ART.</div>\n <div>\n 1.2.3 Participants who have cleared Pf SCP at entry to Step 2 will remain without Pf SCP at day 30 evaluation regardless of the arm to which they were randomized in Step 1.</div>\n <div>\n 1.2.4 Participants with continued Pf SCP at entry to Step 2 will have lower Pf parasite densities at day 30 evaluation compared to day 15 evaluation regardless of the arm they were randomized to in Step 1.</div>\n <div>\n 1.2.5 Gametocyte densities will be lower in participants with Pf SCP who have received 15 days (Step 1) of LPV/r-based compared with nNRTI-based ART.</div>\n <div>\n 1.2.6 Participants with continued Pf SCP at entry to Step 2 will have a higher Pf gametocyte density at day 30 evaluation compared to day 15 evaluation regardless of the arm to which they were randomized in Step 1.</div>\n <div>\n 1.2.7 Mutations in the Pf plasmepsin region in participants receiving LPV/r-based ART will be identified after 15 days (Step 1) of therapy.</div>\n <div>\n 1.3 Primary Objective</div>\n <div>\n To compare the proportions of Pf SCP clearance between LPV/r-based and nNRTI based ART in participants after 15 days of therapy (Step 1).</div>\n <div>\n 1.4 Secondary Objectives</div>\n <div>\n 1.4.1 To compare time to Pf SCP clearance in participants with Pf SCP who have received 15 days of LPV/r-based and nNRTI-based ART.</div>\n <div>\n 1.4.2 To compare Pf parasite densities in participants with Pf SCP who have received 15 days of LPV/r-based and nNRTI-based ART.</div>\n <div>\n 1.4.3 To estimate changes in Pf parasite densities from day 1 to day 30 in four cohorts: (1) randomized to nNRTI-based ART with continued Pf SCP at day 15, (2) randomized to nNRTI-based ART with clearance of Pf SCP at day 15, (3)</div>\n <div>\n <div>\n randomized to LPV/r-based ART with continued Pf SCP at day 15, (4) randomized to LPV/r-based ART with clearance of Pf SCP at day 15.</div>\n <div>\n 1.4.4 To compare Pf gametocyte densities in participants with Pf SCP who have received 15 days of LPV/r-based and nNRTI-based ART.</div>\n <div>\n 1.4.5 To estimate changes in Pf gametocyte densities from day 1 to day 30 in four cohorts: (1) randomized to nNRTI-based ART with continued Pf SCP at day 15, (2) randomized to nNRTI-based ART with clearance of Pf SCP at day 15, (3) randomized to LPV/r-based ART with continued Pf SCP at day 15, (4) randomized to LPV/r-based ART with clearance of Pf SCP at day 15.</div>\n <div>\n 1.4.6 To describe safety and clinical outcomes in participants with Pf SCP who have received 15 days of LPV/r-based and nNRTI-based ART.</div>\n <div>\n 1.4.7 To describe safety and clinical outcomes in participants who enter Step 2 with and without Pf SCP.</div>\n <div>\n 1.4.8 To evaluate whether exposure of Pf parasites to LPV/r results in the selection of signature mutations within the plasmepsin region.</div>\n </div>\n </div>\n</div>\n<p>\n  </p>\n
      • study_title<p>\n <span style=\"font-size: 12px;\">An Open-Label, Proof of Concept, Randomized Trial Comparing a LPV/r-Based to an nNRTI-Based Antiretroviral Therapy Regimen for Clearance of Plasmodium falciparum Subclinical Parasitemia in HIV-infected Adults with CD4+ Counts >200 and < 500 cells/mm3</span></p>\n
      • laymans_summary(null)
      • short_titleA5297
      • protocol_noECCT/14/11/02
      • version_no1.0
      • date_of_protocol29-02-2012
      • study_drugLopinavir/ritonavir, Efavirenz, Trimethoprim/Sulphamethoxazole
      • disease_conditionMalaria and HIV
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameLopinavir/ritonavir, Efavirenz, Nevirapine
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresseayuo@kemricdc.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries1
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
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      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantAMOS K. O. RAGANG\', KEMRI/CDC CLINICAL RESEARCH CENTRE, PO BOX 1578-40100 KISUMU
      • declaration_date101-12-2014
      • declaration_principal_investigatorDR. VICTOR AKELO, KEMRI/CDC CLINICAL RESEARCH CENTRE, PO BOX 1578-40100 KISUMU
      • declaration_date201-12-2014
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n Step 1 Inclusion Criteria</p>\n<ul>\n <li>\n HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load.</li>\n</ul>\n<p>\n Note: The term “licensed” refers to a US FDA-approved kit, which is required for all US sites and recommended for non-US ones. For non-US sites that are unable to obtain an FDA-approved kit, a kit that has been certified or licensed by an oversight body within that country and validated internally is acceptable.</p>\n<p>\n WHO (World Health Organization) and CDC (Center for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (eg, indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load.</p>\n<ul>\n <li>\n CD4+ count > 200 and < 350 cells/mm3 obtained within 30 days prior to study entry at a DAIDS-approved laboratory.</li>\n <li>\n <em>Pf </em>SCP confirmed in a laboratory approved to conduct parasitemia microscopy.</li>\n</ul>\n<p>\n Note: <em>Pf </em>SCP will be defined as meeting all three of the following criteria within 72 hours prior to study entry:</p>\n<ul>\n <li>\n Microscopy confirmed parasitemia (see section 6.3.6 and the A5297 Manual of Procedures [MOPS])</li>\n <li>\n An oral temperature < 37.5°C temperature</li>\n <li>\n The absence of Grade 2 or greater signs or symptoms thought to be related to clinical malaria including:</li>\n</ul>\n<p>\n a. headache</p>\n<p>\n b. malaise or fatigue</p>\n<p>\n c. abdominal discomfort</p>\n<p>\n d. muscle or joint pain</p>\n<p>\n e. fever</p>\n<p>\n f. chills</p>\n<p>\n g. perspiration</p>\n<p>\n h. anorexia</p>\n<p>\n i. vomiting</p>\n<p>\n j. other signs or symptoms thought to be related to clinical malaria</p>\n<ul>\n <li>\n The following laboratory values obtained within 14 days prior to study entry:</li>\n</ul>\n<p>\n  </p>\n<ul style=\"margin-left: 40px;\">\n <li>\n Hemoglobin  7.0 g/dL</li>\n <li>\n  Estimated creatinine clearance of ≥60 mL/min.</li>\n</ul>\n<p>\n Note: Calculation program can be found on DMC website (http://www.fstrf.org/ACTG/index.html).</p>\n<ul style=\"margin-left: 40px;\">\n <li>\n Aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT) ï‚£ 2.5 ï‚´ ULN</li>\n <li>\n Hepatitis B surface antigen (HBsAg) negative within 30 days prior to entry.</li>\n <li>\n Female study volunteers of reproductive potential must have a negative serum or urine pregnancy test performed within 72 hours prior to entry.</li>\n</ul>\n<p>\n NOTE: Female study volunteers of reproductive potential are defined as women who have reached menarche or who have not been post-menopausal for at least 24 consecutive months {i.e., who have had menses within the preceding 24 months and have not undergone a sterilization procedure (eg, hysterectomy, bilateral oophorectomy, or salpingectomy)}.</p>\n<ul>\n <li>\n All study volunteers must agree not to participate in a conception process (eg, active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) for study duration.</li>\n</ul>\n<p>\n  </p>\n<p>\n If participating in sexual activity that could lead to pregnancy, all study volunteers must agree to use two reliable forms of contraceptive simultaneously while receiving protocol-specified medications. One form of contraceptive must be a barrier method if a participant receives EFV. Participants must agree to continue the use of two contraceptives for 6 months after stopping EFV and 6 weeks after stopping all other protocol-specified medications.</p>\n<p>\n Note: Female participants who are unable to meet the contraception requirements for EFV should be encouraged to consider NVP.</p>\n<p>\n Study volunteers who are not of reproductive potential (girls who have not reached menarche, or women who have been post-menopausal for at least 24 consecutive months, or women who have undergone hysterectomy, bilateral oophorectomy or salpingectomy, or men who have documented azoospermia) are eligible without requiring the use of a contraceptive. Acceptable documentation of sterilization, other contraceptive methods, and menopause are written documentation or oral communication from a clinician or clinician’s staff documented in source documents of one of the following:</p>\n<p>\n ï‚· Physician report/letter</p>\n<p>\n ï‚· Operative report or other source documentation in the patient record</p>\n<p>\n ï‚· Discharge summary</p>\n<p>\n ï‚· Laboratory report of azoospermia (is required to document successful vasectomy)</p>\n<p>\n ï‚· FSH measurement elevated into the menopausal range as established by the reporting laboratory for EFV and per participant’s history for all other drugs.</p>\n<p>\n  </p>\n<ul>\n <li>\n Men and women age  18 years.</li>\n</ul>\n<p>\n  </p>\n<ul>\n <li>\n Ability and willingness of participant or legal guardian/representative to provide informed consent.</li>\n</ul>\n<p>\n  </p>\n<ul>\n <li>\n Willing and able to return to the clinic twice to three times a day for study visits.</li>\n</ul>\n<p>\n  </p>\n<p>\n Step 2: Inclusion Criteria</p>\n<ul>\n <li>\n Completion of Step 1</li>\n</ul>\n
      • principal_exclusion_criteria<p>\n Step 1: Exclusion Criteria</p>\n<ul>\n <li>\n Previous history or current use of ART.</li>\n <li>\n Single dose NVP or dual therapies used for PMTCT within 2 years prior to entry.</li>\n <li>\n Use of any medication with antimalarial activity, including TMP/SMX (see list of prohibited medications in the A5297 MOPS), within 14 days prior to study entry.</li>\n <li>\n Confirmed or clinically suspected OIs (including but not limited to tuberculosis, clinical malaria, <em>PCP</em>), or other pulmonary or gastrointestinal infections for which potential participants did not complete treatment more than 30 days prior to enrollment or have signs and symptoms during screening.</li>\n <li>\n Breastfeeding.</li>\n <li>\n Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation.</li>\n <li>\n Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.</li>\n <li>\n Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry.</li>\n <li>\n Results suggestive of active pulmonary disease from a chest x-ray performed within 30 days prior to study entry.</li>\n</ul>\n<p>\n Step 2: Exclusion Criteria</p>\n<p>\n There are no exclusion criteria for Step 2</p>\n
      • primary_end_points<p>\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial,helvetica,sans-serif;\">The primary endpoint is PCR defined clearance of <i>Pf </i>parasitemia defined as < 10 parasites/μL on three consecutive occasions within a 24-hour period. </span></span></p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic1
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p style=\"margin: 0in 0in 0pt;\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial,helvetica,sans-serif;\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">Dr. Victor Akelo<o:p></o:p></span></span></span></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial,helvetica,sans-serif;\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">MBChB, MPH<o:p></o:p></span></span></span></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial,helvetica,sans-serif;\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">Principal Investigator and Study Medical Officer<o:p></o:p></span></span></span></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial,helvetica,sans-serif;\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">HIVR Research Branch<o:p></o:p></span></span></span></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial,helvetica,sans-serif;\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">KEMRI/CDC, (Kisumu)<o:p></o:p></span></span></span></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial,helvetica,sans-serif;\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">Will oversee daily study operations and implementation.  Will supervise Kisumu-based study staff.  Substantial input into site-specific study design, protocol development and assessment tools.  Will guide study implementation, data analysis and report writing.  Will be a member of the protocol team.</span></span></span></p>\n<p style=\"margin: 0in 0in 0pt;\">\n  </p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">Frank Angira<o:p></o:p></span></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">DCM, ADPH, MPH (c)<o:p></o:p></span></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">Co-Principal Investigator and Study Coordinator<o:p></o:p></span></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">KEMRI/CDC (Kisumu)<o:p></o:p></span></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">Will provide input for data analysis and will write report. Will be a member of the protocol team with substantial input into site-specific study design, protocol development and assessment tools.  Will assist with study implementation, data analysis and report writing. Will coordinate all field components of the study, will interact daily with the study participants, study team and investigators.<o:p></o:p></span></p>\n<p>\n  </p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">Clement Zeh<o:p></o:p></span></span></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">MPH, PhD<o:p></o:p></span></span></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">Co-Principal Investigator<o:p></o:p></span></span></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">KEMRI/CDC (Kisumu)<o:p></o:p></span></span></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">Will provide input for data analysis and will write report. Will oversee all laboratory aspects of the study. Will be a member of the protocol team with substantial input into site-specific study design, protocol development and assessment tools.  Will assist with study implementation and report writing.<o:p></o:p></span></span></p>\n<p>\n  </p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial,helvetica,sans-serif;\"><font color=\"#000000\"><span new=\"\" style=\"line-height: 115%;\" times=\"\"><span style=\"color: black; font-family:;\">Kevin Cain </span><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\"><o:p></o:p></span></span></font></span></span></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial,helvetica,sans-serif;\"><font color=\"#000000\"><span new=\"\" style=\"line-height: 115%;\" times=\"\"><span style=\"color: black; font-family:;\">MD</span><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\"><o:p></o:p></span></span></font></span></span></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial,helvetica,sans-serif;\"><font color=\"#000000\"><span new=\"\" style=\"line-height: 115%;\" times=\"\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">Co-Investigator<o:p></o:p></span></span></font></span></span></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial,helvetica,sans-serif;\"><font color=\"#000000\"><span new=\"\" style=\"line-height: 115%;\" times=\"\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">The Kisumu CRS leader. Will provide substantial input into the site-specific study design, protocol development and assessment tools. Will assist with study implementation, data analysis and report writing.  </span></span></font></span></span></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial,helvetica,sans-serif;\"><font color=\"#000000\"><span new=\"\" style=\"line-height: 115%;\" times=\"\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\"><o:p></o:p></span> </span></font></span></span></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <font color=\"#000000\"><span new=\"\" style=\"line-height: 115%;\" times=\"\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">Aaron Samwels<o:p></o:p></span></span></span></font></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <font color=\"#000000\"><span new=\"\" style=\"line-height: 115%;\" times=\"\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">MD, MHS<o:p></o:p></span></span></span></font></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <font color=\"#000000\"><span new=\"\" style=\"line-height: 115%;\" times=\"\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">Co-investigator<o:p></o:p></span></span></span></font></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <font color=\"#000000\"><span new=\"\" style=\"line-height: 115%;\" times=\"\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\"><span lang=\"EN\" style=\"color: rgb(34, 34, 34); font-family:;\">Will provide substantial input into site-specific study design, protocol development and assessment tools. Will assist with study implementation, data analysis and report writing<o:p></o:p></span></span></span></font></p>\n<p>\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial,helvetica,sans-serif;\"><font color=\"#000000\"><span new=\"\" style=\"line-height: 115%;\" times=\"\"> </span></font></span></span></p>\n<p style=\"margin: 0in 0in 0pt;\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial,helvetica,sans-serif;\"><font color=\"#000000\"><span new=\"\" style=\"line-height: 115%;\" times=\"\"> </span></font></span></span></p>\n<p>\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial,helvetica,sans-serif;\"><font color=\"#000000\"> </font></span></span></p>\n<p>\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial,helvetica,sans-serif;\"> </span></span></p>\n<p>\n <span style=\"font-size: 12px;\"> </span></p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial,helvetica,sans-serif;\">The study sponsors are based in the united states.The study aims to enrol participants with parasitemia and also infected with HIV, such population is not readily available in the sponsor country. The study is thus restricted to limited resource setting, and the implementing countries are thus considered as such. <span style="line-height: 115%; mso-ansi-language: EN-US; mso-ascii-theme-font: minor-latin;" minor-fareast;="" minor-latin;="" "times="" roman";="" minor-bidi;="" en-us;="" ar-sa;"="" new="" times=""><font color=\"#000000\">As at 24^th November 2014, the study had enrolled a total of 9 participants out of the targeted 52 across all the participating clinical research sites (CRS)</font></span></span></p>\n<p>\n  </p>\n<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" width=\"691\">\n <tbody>\n <tr>\n <td nowrap=\"nowrap\" style=\"width: 67px; height: 20px;\">\n <p>\n <strong>Country</strong></p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 72px; height: 20px;\">\n <p>\n <strong>City</strong></p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 132px; height: 20px;\">\n <p>\n <strong>Clinical Research Site </strong></p>\n </td>\n <td style=\"width: 52px; height: 20px;\">\n <p>\n <strong>Site ID</strong></p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 176px; height: 20px;\">\n <p>\n <strong>Clinical trial Unit Name</strong></p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 126px; height: 20px;\">\n <p>\n <strong>Date Activated </strong></p>\n </td>\n <td style=\"width: 66px; height: 20px;\">\n <p>\n <strong>Number Enrolled </strong></p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width: 67px; height: 40px;\">\n <p>\n Uganda</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 72px; height: 40px;\">\n <p>\n Kampala</p>\n </td>\n <td style=\"width: 132px; height: 40px;\">\n <p>\n Joint Clinical Research Centre /Kampala CRS</p>\n </td>\n <td style=\"width: 52px; height: 40px;\">\n <p>\n 12401</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 176px; height: 40px;\">\n <p>\n Case CTU</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 126px; height: 40px;\">\n <p>\n 6^th May 2013</p>\n </td>\n <td style=\"width: 66px; height: 40px;\">\n <p>\n Zero (0)</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width: 67px; height: 63px;\">\n <p>\n Malawi</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 72px; height: 63px;\">\n <p>\n Lilongwe</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 132px; height: 63px;\">\n <p>\n Malawi CRS</p>\n </td>\n <td style=\"width: 52px; height: 63px;\">\n <p>\n 12001</p>\n </td>\n <td style=\"width: 176px; height: 63px;\">\n <p>\n University of North Carolina Global HIV prevention and treatment CTU</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 126px; height: 63px;\">\n <p>\n 22^nd April 2013</p>\n </td>\n <td style=\"width: 66px; height: 63px;\">\n <p>\n Zero (0)</p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 67px; height: 40px;\">\n <p>\n Kenya</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 72px; height: 40px;\">\n <p>\n Kericho</p>\n </td>\n <td style=\"width: 132px; height: 40px;\">\n <p>\n KEMRI/WRP CRS</p>\n </td>\n <td style=\"width: 52px; height: 40px;\">\n <p>\n 12501</p>\n </td>\n <td style=\"width: 176px; height: 40px;\">\n <p>\n United States Military HIV Research Program CTU</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 126px; height: 40px;\">\n <p>\n 26^th June 2013</p>\n </td>\n <td style=\"width: 66px; height: 40px;\">\n <p>\n Nine (9)</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width: 67px; height: 40px;\">\n <p>\n Kenya</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 72px; height: 40px;\">\n <p>\n Eldoret</p>\n </td>\n <td style=\"width: 132px; height: 40px;\">\n <p>\n Moi University CRS</p>\n </td>\n <td style=\"width: 52px; height: 40px;\">\n <p>\n 12601</p>\n </td>\n <td style=\"width: 176px; height: 40px;\">\n <p>\n United States Military HIV Research Program CTU</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 126px; height: 40px;\">\n <p>\n 22^nd October 2013</p>\n </td>\n <td style=\"width: 66px; height: 40px;\">\n <p>\n Zero (0)</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width: 67px; height: 60px;\">\n <p>\n Kenya</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 72px; height: 60px;\">\n <p>\n Kisumu</p>\n </td>\n <td style=\"width: 132px; height: 60px;\">\n <p>\n KEMRI/CDC CRS</p>\n </td>\n <td style=\"width: 52px; height: 60px;\">\n <p>\n 31460</p>\n </td>\n <td style=\"width: 176px; height: 60px;\">\n <p>\n Emory-CDC CTU</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 126px; height: 60px;\">\n <p>\n Not yet activated</p>\n </td>\n <td style=\"width: 66px; height: 60px;\">\n <p>\n N/A</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width: 67px; height: 40px;\">\n <p>\n Malawi</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 72px; height: 40px;\">\n <p>\n Blantyre</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 132px; height: 40px;\">\n <p>\n Blantyre CRS</p>\n </td>\n <td style=\"width: 52px; height: 40px;\">\n <p>\n 30301</p>\n <p>\n  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 176px; height: 40px;\">\n <p>\n The John Hopkins University-Blantyre CTU</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 126px; height: 40px;\">\n <p>\n Not yet activated</p>\n </td>\n <td style=\"width: 66px; height: 40px;\">\n <p>\n N/A</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width: 67px; height: 44px;\">\n <p>\n India</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 72px; height: 44px;\">\n <p>\n Chennai</p>\n </td>\n <td style=\"width: 132px; height: 44px;\">\n <p>\n Chennai Antiviral research and treatment CRS</p>\n </td>\n <td style=\"width: 52px; height: 44px;\">\n <p>\n 11701</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 176px; height: 44px;\">\n <p>\n University of California CTU</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width: 126px; height: 44px;\">\n <p>\n Not yet activated</p>\n </td>\n <td style=\"width: 66px; height: 44px;\">\n <p>\n N/A</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n
      • other_details_regulatory_notapproved<p>\n NONE</p>\n
      • other_details_regulatory_approved<p>\n KEMRI SSC</p>\n<p>\n KEMRI ERC</p>\n<p>\n CDC IRB (with reliance on KEMRI)</p>\n
      • other_details_regulatory_rejected<p>\n NONE</p>\n
      • other_details_regulatory_halted<p>\n NONE</p>\n
      • estimated_duration30days
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorLopinavir/Ritonavir regim
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI/CDC CLINICAL RESEARCH CENTRE
      • single_site_physical_addressWITHING JARAMOGI OGINGA ODINGA TEACHING & REFERRAL HOSPITAL
      • single_site_contact_personDr. Kevin Cain
      • single_site_telephone+254-57-2022929
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states4
      • number_of_sites
      • multi_country_listUganda, Malawi, Kenya, India
      • data_monitoring_committeeYes
      • total_enrolment_per_site25-30
      • total_participants_worldwide52
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameJohnstone
      • investigator1_middle_name
      • investigator1_family_nameKumwenda
      • investigator1_qualificationMD
      • investigator1_professional_addressCollege of Medicine-Johns Hopkins Project Chipatala Avenue
      • investigator1_telephone265-187-0132 x 307
      • investigator1_emailjkumwenda@jhu.medcol.mw
      • organisations_transferred_No
      • number_participants25-30
      • notification
      • approval_date02-02-2015
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted03-12-2014
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2017-02-28 14:21:21
      • created2014-11-25 13:47:01
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id246
        • application_id351
        • given_nameVICTOR
        • middle_name
        • family_nameAKELO
        • qualificationMSc. Public Health, MBA(cont.), MBChB
        • professional_addressPO BOX 1578 - 40100, KEMRI/CDC, KISUMU
        • telephone057 2022902/59/02
        • emailvakelo@kemricdc.org
        • created2014-11-25 13:59:56
        • modified2014-12-03 15:39:08
    • SiteDetail(array)
      • 0(array)
        • id297
        • application_id351
        • county_id42
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2014-11-25 13:59:56
        • modified2014-12-03 15:39:08
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id186
        • application_id351
        • sponsorNational Institute of Allergy and Infectious Diseases (DAIDS)
        • sponsor_type(null)
        • contact_personEileen Pouliot
        • address6700-B Rockledge Drive Room 3214, MSC 7612 Bethesda, Maryland 20892-7612
        • telephone_number+1-240-499-2239
        • fax_number
        • cell_number+1-240-499-2239
        • email_addressNIAIDOCSO@niaid.nih.gov
        • created2014-11-25 13:59:56
        • modified2014-12-03 15:39:08
  • 1(array)
    • Application(array)
      • id350
      • user_id224
      • trial_status_id7
      • abstract_of_study<p>\n Acute venous thromboembolism (i.e. deep-vein thrombosis [DVT] or pulmonary<br />\n embolism [PE]) is a common disorder with an annual incidence of approximately 1<br />\n or 2 cases per 1000 persons in the general population and is the third most common<br />\n cause of vascular death after myocardial infarction and stroke. The current standard<br />\n treatment for DVT is overlapping parenteral anticoagulation (e.g. LMWH) and a<br />\n vitamin K antagonist (e.g. warfarin). Parenteral anticoagulation needs to be<br />\n continued for 5 to 7 days, at least until an INR of 2.0 has been obtained, followed by<br />\n a minimum of 3 months of treatment with the vitamin K antagonist. Treatment with<br />\n vitamin K antagonists requires frequent monitoring of the international normalized<br />\n ratio (INR), and multiple interactions of vitamin K antagonists with foods and other<br />\n drugs have been reported. The duration of treatment is determined by individual risk<br />\n factors of the patient.<br />\n Rivaroxaban is a direct factor Xa inhibitor, and has been approved first in the<br />\n prevention of venous thromboembolism after elective hip and knee replacement<br />\n surgery. It does not require routine laboratory monitoring and has no food<br />\n interactions and only a few drug interactions compared to standard of care.<br />\n As part of the development program, the EINSTEIN clinical trial program was<br />\n designed to evaluate the use of rivaroxaban for the acute treatment and secondary<br />\n prevention of DVT (EINSTEIN-DVT) and PE (EINSTEIN-PE) and in long-term<br />\n secondary prevention of recurrent DVT and PE (EINSTEIN-EXT). A unique aspect<br />\n of the EINSTEIN-DVT and PE studies is the use of rivaroxaban as a single agent<br />\n (single drug approach) in contrast to the use of intravenous anticoagulants and<br />\n VKAs.<br />\n The EINSTEIN-DVT study demonstrated that rivaroxaban is at least as effective as<br />\n the current standard therapy with similar safety, in the treatment and secondary<br />\n prevention of DVT. The EINSTEIN PE study demonstrated non-inferior efficacy of<br />\n rivaroxaban compared to standard of care with similar rates of major and clinically<br />\n relevant non-major bleeding. EINSTEIN PE further demonstrated a significant<br />\n reduction of major bleeding events in patients treated with rivaroxaban compared to<br />\n standard of care. EINSTEIN-EXT demonstrated that continued treatment with<br />\n rivaroxaban after 6 or 12 months initial treatment is superior in preventing<br />\n recurrences, as compared with placebo, and has an acceptable risk of bleeding.<br />\n At the time of writing, rivaroxaban is approved by the EMA, the FDA, Singapore,<br />\n Malaysia, Indonesia, Philippines, Taiwan, Korea and Mexico, Brazil, Argentina,<br />\n Chile, Colombia, Peru, Ecuador, Uruguay, and several other countries in Latin<br />\n America as well as in the EMEA region Saudi Arabia, Egypt, Middle Africa, UAE,<br />\n Kuwait, Qatar, Turkey, Jordan, Lebanon, Russia, Kazakhstan and Algeria for the<br />\n treatment of acute DVT, PE and recurrent VTE following DVT or PE in adults. The<br />\n approved dose is 15mg bid for the first 21 days followed by 20mg od for the<br />\n continuing treatment period. Further dosing information are listed in detail in the<br />\n Summary of Product Characteristics (SmPC). In the European Union and other<br />\n countries, rivaroxaban is the first agent that allows treatment of thrombotic events<br />\n with a single drug approach. Treatment with rivaroxaban can be already initiated at<br />\n diagnosis and does not require intravenous/subcutaneous heparin or VKA anymore.<br />\n If the decision is made to switch treatment from rivaroxaban to current standard of<br />\n care, adequate anticoagulation has to be ensured. In patients converting from rivaroxaban to VKA, VKA should be given concurrently until the INR is ≥2.0.<br />\n Patients converting from rivaroxaban to parenteral anticoagulation should receive<br />\n the parenteral anticoagulant at the time originally scheduled for the intake of<br />\n rivaroxaban.<br />\n Bayer conducts the XALIA LEA study to yield complementary post-authorization<br />\n information in rivaroxaban or standard therapy patients under real-life conditions.</p>\n
      • study_title<p>\n XALIA LEA- Xarelto® for Long-term and<br />\n Initial Anticoagulation in Venous<br />\n Thromboembolism (VTE) in Latin America,<br />\n EMEA and Asia</p>\n
      • laymans_summary(null)
      • short_titleRivaroxaban for Long-term and Initial Anticoagulation in Venous Thromboembolism (VTE)
      • protocol_noECCT/14/12/01
      • version_noXA1402 (Impact No. 17237), Protocol Version 1.0
      • date_of_protocol18-02-2014
      • study_drugBay 59-7939, Rivaroxaban, Xarelto®
      • disease_conditionTreatment of deep vein thrombosis (DVT)
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameRivaroxaban
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressselina.musalia@bayer.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries1
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantJohn Mwangi (john.mwangi@bayer.com)
      • declaration_date103-12-2014
      • declaration_principal_investigatorDr. Anne Njambi,Dr Allibhoy Ali, Dr Charles Kariuki,Dr Martin Wanyoike
      • declaration_date203-12-2014
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n ï‚· Female or male patients, who are at >=18 years<br />\n ï‚· Diagnosis of acute DVT and/or PE, objectively confirmed<br />\n ï‚· Indication for anticoagulation therapy for at least 12 weeks<br />\n ï‚· Willing to participate in this study and available for follow-up</p>\n
      • principal_exclusion_criteria<p>\n Exclusion criteria must be read in conjunction with the local product information.<br />\n Patients who are found to receive treatment contrary to the local product information<br />\n will not be excluded. Depending on the number of patients receiving rivaroxaban<br />\n contrary to the local product information these patients can be analyzed in a separate<br />\n analysis. Further details will be described in the SAP.<br />\n  </p>\n
      • primary_end_points<p>\n Major bleedings defined as overt bleeding associated with:<br />\n  A fall in hemoglobin of ≥2 g/dL, or<br />\n  A transfusion of ≥2 units of packed red blood cells or whole blood, or<br />\n  Occurrence at a critical site: intracranial, intra-spinal, intraocular,<br />\n pericardial, intra-articular, intra-muscular with compartment syndrome,<br />\n retroperitoneal<br />\n  Death<br />\n o Symptomatic recurrent venous thromboembolic events confirmed by objective<br />\n diagnostic tools<br />\n o All-cause mortality<br />\n  </p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n Prime Care Heart Clinic. Number of Staff:3</p>\n<p>\n Dr Silversteins Clinic.Number of Staff: 2</p>\n<p>\n Nairobi Cardiovascular Clinic.Number of Staff: 3</p>\n<p>\n Agakhan Kisumu:Number of staff 1</p>\n<p>\n Please refer to CVs attached.</p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n A similar study the Rivaroxaban Once daily oral direct Factor Xa inhibition Compared with vitamin K antagonist for the prevention of stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) study was conducted to evaluate the efficacy and safety of rivaroxaban compared to the VKA warfarin in the prevention of thromboembolic events in subjects with non-valvular AF was conducted in the host country.</p>\n<p>\n The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of acute DVT and/or PE in routine clinical practice use in Latin America, Eastern Europe, Middle East and Africa.</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n None</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_duration12 months
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states10
      • number_of_sitesMultiple
      • multi_country_listLatin America, Eastern Europe,Middle East and Asia
      • data_monitoring_committeeYes
      • total_enrolment_per_site100
      • total_participants_worldwide2500
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameDavid Kuria Kamau
      • investigator1_middle_nameKuria
      • investigator1_family_nameKamau
      • investigator1_qualificationMBChB , M.Med
      • investigator1_professional_addressPrime care heart clinic ,Nairobi Hospital, Nairobi Kenya
      • investigator1_telephone+254 722 578 308
      • investigator1_emailkuriakamau@gmail.com
      • organisations_transferred_No
      • number_participants100
      • notification
      • approval_date27-01-2015
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted04-12-2014
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2017-05-05 10:34:58
      • created2014-11-06 14:24:03
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id242
        • application_id350
        • given_nameAnne Njeri Mugera
        • middle_nameNjambi
        • family_nameMugera
        • qualificationMBChB, Mmed
        • professional_addressDr. Silversteins Clinic, Nairobi Hospital ,Nairobi Kenya.
        • telephone+254 722 747 695
        • emaildrannemugeraknh@gmail.com
        • created2014-11-06 14:55:10
        • modified2014-12-04 10:39:27
      • 1(array)
        • id243
        • application_id350
        • given_nameDr. Martin N Wanyoike
        • middle_nameNjoroge
        • family_nameWanyoike
        • qualificationMBChB,M.Med ,CTM
        • professional_addressPrime Care Heart Clinic , Nairobi Hospital, Nairobi Kenya
        • telephone+254 720 921 553
        • emailprimecareheartclinic@gmail.com
        • created2014-11-06 15:07:54
        • modified2014-12-04 10:39:27
      • 2(array)
        • id244
        • application_id350
        • given_nameCharles Muthui Kariuki
        • middle_nameMuthui
        • family_nameKariuki
        • qualificationMBChB,MRCP,M.Med,FRCP
        • professional_addressNairobi Cardiovascular Clinic, NairobI Hospital ,Nairobi ,Kenya
        • telephone+254 733 370 057
        • emailckthreesk@gmail.com
        • created2014-11-06 15:13:05
        • modified2014-12-04 10:39:27
      • 3(array)
        • id245
        • application_id350
        • given_nameFEROZ ALI
        • middle_name
        • family_nameAllibhoy
        • qualificationMBBS
        • professional_addressP.O Box 530 Kisumu
        • telephone(057)2020005 / 2023300
        • emaildr.f.allibhoy@live.com
        • created2014-11-10 16:11:56
        • modified2014-12-04 10:39:27
    • SiteDetail(array)
      • 0(array)
        • id293
        • application_id350
        • county_id47
        • site_namePrimecare Heart Clinic
        • physical_addressPrime care Heart clinic Nairobi Hospital , Nairobi , Kenya
        • contact_detailsP.O.BOX 19552-00202 NAIROBI
        • contact_personDr. Martin Wanyoike
        • site_capacity(null)
        • misc(null)
        • created2014-11-06 14:55:10
        • modified2014-12-04 10:39:27
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id294
        • application_id350
        • county_id47
        • site_nameDr. Silversteins Clinic
        • physical_addressDr.Silversteins Clinic , Nairobi Hospita Nairobi Kenya.
        • contact_details+254 722 747 695
        • contact_personDr.Anne Mugera
        • site_capacity(null)
        • misc(null)
        • created2014-11-06 15:35:33
        • modified2014-12-04 10:39:27
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 2(array)
        • id295
        • application_id350
        • county_id47
        • site_nameNairobi Cardiovascular Clinic
        • physical_addressNairobi Cardiovascular Clinic,Nairobi Hospital, Nairobi Kenya
        • contact_details+254 733 370 057
        • contact_personDr.Charles Kariuki
        • site_capacity(null)
        • misc(null)
        • created2014-11-06 15:35:33
        • modified2014-12-04 10:39:27
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 3(array)
        • id296
        • application_id350
        • county_id42
        • site_nameAgah Khan Kisumu
        • physical_addressKisumu
        • contact_detailsP.O Box 530 Kisumu
        • contact_personDr Allibhoy Feroz Ali
        • site_capacity(null)
        • misc(null)
        • created2014-11-10 16:13:39
        • modified2014-12-04 10:39:28
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id185
        • application_id350
        • sponsorBayer HealthCare AG, Germany
        • sponsor_type(null)
        • contact_personChristopher Maina Wairegi
        • address30321-00100 Thika Road/Outering road , Ruaraka
        • telephone_number+254 20 8600000
        • fax_number+254 20 8600010
        • cell_number+254 700 390 311
        • email_addresschristopher.wairegi@bayer.com
        • created2014-11-06 14:55:10
        • modified2014-12-04 10:39:27
  • 2(array)
    • Application(array)
      • id346
      • user_id81
      • trial_status_id5
      • abstract_of_study<p>\n Previous Ebola outbreaks have been limited to individual countries and contained by infection control activities.  The current outbreak in West Africa is international, and air travel has resulted in a number of infected travellers crossing national borders.  Although Kenya has not previously experienced outbreaks of Ebola, we are now at particular risk because of Kenya’s role as a hub for international travel.  There are currently no specific treatments generally available for Ebola and the mortality is high, particularly in countries with limited intensive care facilities.  There is currently no vaccine and the personal protection required by healthcare workers treating patients is cumbersome and requires full compliance to be protective.<br />\n We are conducting this trial, a Phase I, open-label, dose escalation trial, designed to establish safety, tolerability and immunogenicity of two doses of VSVΔG-ZEBOV, an Ebola Virus Vaccine Candidate for the first time in sub-Saharan African populations.  There is now a consortium (VEBCON collaboration) of four clinical centres (in Kenya, Gabon, Switzerland and Germany), WHO and New Link Genetics (the vaccine manufacturer) under which this study will be conducted.<br />\n We plan to vaccinate 40 volunteers in Kenya.  The trial will be conducted at the KEMRI-CGMR Coast site where healthcare workers (both clinical and laboratory) will be the primary target population as they are likely to be the recipients of a protective vaccine.  We will vaccinate a cohort of 20 volunteers at a low dose and then vaccinate a further cohort of 20 volunteers at full dose. Each volunteer will receive one dose of the vaccine.  We will follow them up for a period of one year looking to their safety and immunogenicity endpoints.</p>\n
      • study_title<address>\n <address>\n <strong>A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of the BPSC1001 (VSVΔG-ZEBOV) Ebola Virus Vaccine Candidate in Healthy Adult Volunteers in Kilifi, Kenya.</strong></address>\n</address>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n
      • laymans_summary<address>\n <strong><u> A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of the BPSC1001 (VSVΔG-ZEBOV) Ebola Virus Vaccine Candidate in Healthy Adult Volunteers in Kilifi, Kenya.</u></strong></address>\n<address>\n <strong><u>Lay title: A study to find out if a new Ebola vaccine is safe and may protect adults.</u></strong></address>\n<address>\n <strong>What is the problem/background?</strong></address>\n<address>\n Ebola is a disease that occurs in epidemics. So far it occurs in outbreaks and more than half of the affected people die from the disease. Currently there is an outbreak in West and Central Africa that has affected over 7,000 people with over 3,000 deaths. There is no treatment or vaccine for Ebola. The therapies available currently are still in development and have not been licenced for use in humans. The World Health Organisation together with the vaccine manufacturer have asked a few research centres to be involved in the testing of this vaccine of which we are one centre.</address>\n<address>\n <strong>What questions are we trying to answer?</strong></address>\n<address>\n Is this Ebola vaccine safe to give in adults in Kilifi? Does this Ebola vaccine lead to an immune response in adults in Kilifi?</address>\n<address>\n <strong>Where is the study taking place, how many people does it involve and how are they selected?</strong></address>\n<address>\n The study will be carried out at the KEMRI –CGMR Coast in Kilifi. We aim to enroll 40 adults (health workers) in this study. They will be volunteers following dissemination talks and those interested will be invited to get further information on the study. They will then make a decision to be included in the study.</address>\n<address>\n <strong>What does the study involve for those who are in it?</strong></address>\n<address>\n The volunteers will sign the informed consent to indicate their willingness to be involved in the study. They will undergo a clinical examination and tests to ensure that they are healthy. They will receive one dose of the vaccine and then have 10 follow-up visits over 1 year.  </address>\n<address>\n <strong>What are the benefits and risks/costs of the study for those involved?  </strong></address>\n<address>\n The benefits will be thorough clinical tests which might identify problems not previously identified. There will be some risks from the procedures such as pain and discomfort. There may be a reaction to the vaccine such as fever, pain or general malaise. There may be rare and unexpected risks such as an allergic reaction.</address>\n<address>\n <strong>How will the study benefit society?  </strong></address>\n<address>\n Should this study prove the vaccine to be safe and show an immune response, it may provide the basis for use in outbreak situation. </address>\n<address>\n <strong>When does the study start and finish?  </strong></address>\n<address>\n The study will run for 1 year<strong>. </strong></address>\n<p>\n <br />\n <br />\n  </p>\n
      • short_titleZEBOV Trial
      • protocol_noECCT/14/11/01
      • version_noVersion 1.4 dated 30 October 2014
      • date_of_protocol30-10-2014
      • study_drugBPSC1001 (VSVΔG-ZEBOV) Ebola Virus Vaccine Candidate
      • disease_conditionEbola haemorrhagic fever or Ebola virus disease
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressctfuser@kemri-wellcome.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi0
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantPhilip Bejon
      • declaration_date120-11-2014
      • declaration_principal_investigatorPatricia Njuguna
      • declaration_date220-11-2014
      • placebo_presentNo
      • study_objectives<address>\n <span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"font-size:12px;\"><em>To evaluate VSV vaccine viraemia using PCR after administration of VSVG-ZEBOV vaccine<strong>.</strong></em></span></span></address>\n<address>\n <address>\n <span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"font-size:12px;\"><em>To evaluate the ZEBOV-specific antibody responses induced by VSVΔG-ZEBOV vaccine<strong>.</strong></em></span></span></address>\n <address>\n <address>\n <span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"font-size:12px;\"><em>To evaluate VSV vaccine viraemia using PCR after administration of VSVG-ZEBOV vaccine<strong>.</strong></em></span></span></address>\n </address>\n</address>\n
      • principal_inclusion_criteria<p>\n • Have provided written informed consent prior to screening procedures (i.e. participants must be literate).<br />\n • Healthy adult male or non-pregnant, non-lactating female, ages 18 to 55 (inclusive) at the time of screening<br />\n • Free of clinically significant health problems, as determined by pertinent medical history, clinical examination and blood tests at screening<br />\n • Available, able, and willing to participate for all study visits and procedures<br />\n • Negative pregnancy-test for female volunteers<br />\n • Females, of non-childbearing potential who are post-menopausal (i.e. ≥ one year without menses) or surgically sterilized (tubal ligation, bilateral oophorectomy, or hysterectomy)<br />\n • Females, of childbearing potential, who are willing to use effective methods of contraception for 14 days before vaccination and 30 days after vaccination.<br />\n • Males who are willing to use effective contraception following vaccination for a period of one week.<br />\n • Be willing to minimize blood and body fluid exposure of others for 5 days after vaccination<br />\n �</p>\n
      • principal_exclusion_criteria<p>\n • History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions.<br />\n • Known allergy to the components of the BPSC1001 vaccine product<br />\n • Unable or unwilling to stay in the study area for the period of the study and comply with study procedures.<br />\n • Ongoing participation in another clinical trial<br />\n • Receipt of licensed vaccines within 14 days of planned study immunization (30 days for live vaccines)<br />\n • Acute or chronic, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the investigator based on medical history, physical exam, and/or laboratory screening test<br />\n • Any serologic evidence of hepatitis B SAg or HIV infection.<br />\n • Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 5 years, and/or uncontrolled diabetes<br />\n • Have an active malignancy or history of metastatic or hematologic malignancy<br />\n • Suspected or known alcohol and/or illicit drug abuse within the past 5 years<br />\n • Moderate or severe illness and/or fever >38°C within 2 weeks prior to vaccination<br />\n • Pregnant or lactating woman or a woman who intends to become pregnant within 30 days following vaccination.<br />\n • Administration of immunoglobulins and/or any blood products within the 120 days preceding study entry or planned administration during the study period<br />\n • Administration of chronic (defined as more than 14 days) immunosuppressant’s or other immune modifying drugs within 6 months of study entry<br />\n • Any other significant finding that in the opinion of the investigator would increase the risk of the individual having an adverse outcome from participating in this study</p>\n<p>\n �</p>\n
      • primary_end_points<p>\n 1. The incidence of adverse events (AEs) and/or serious adverse events (SAEs) causally inked to the study intervention in the first 14 and 30 days respectively.</p>\n<p>\n 2. The titres of� ZEBOV-specific IgG antibodies.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response1
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyPhase 1, Dose escalation
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" height=\"167\" width=\"628\">\n <colgroup>\n <col />\n <col />\n <col />\n <col />\n <col />\n </colgroup>\n <tbody>\n <tr height=\"17\">\n <td height=\"17\" style=\"height:17px;width:111px;\">\n Staff role�</td>\n <td style=\"width:83px;\">\n Number�</td>\n <td style=\"width:131px;\">\n Name�</td>\n <td style=\"width:131px;\">\n Qualifications�</td>\n <td style=\"width:144px;\">\n Years of Experience�</td>\n </tr>\n <tr height=\"17\">\n <td height=\"17\" style=\"height:17px;\">\n PI</td>\n <td>\n 1</td>\n <td>\n Philip Bejon</td>\n <td>\n PhD / MBBS</td>\n <td>\n 15</td>\n </tr>\n <tr height=\"17\">\n <td height=\"17\" style=\"height:17px;\">\n Co-PI / Co-ordinator</td>\n <td>\n 1</td>\n <td>\n Patricia Njuguna�</td>\n <td>\n MMed</td>\n <td>\n 10</td>\n </tr>\n <tr height=\"17\">\n <td height=\"17\" style=\"height:17px;\">\n Nurse�</td>\n <td>\n 1</td>\n <td>\n Anderson Kahindi</td>\n <td>\n KRN</td>\n <td>\n 20</td>\n </tr>\n <tr height=\"17\">\n <td height=\"17\" style=\"height:17px;\">\n Medical officer</td>\n <td>\n 1</td>\n <td>\n Caroline Ogwang</td>\n <td>\n MBCHB</td>\n <td>\n 6</td>\n </tr>\n <tr height=\"17\">\n <td height=\"17\" style=\"height:17px;\">\n Pharmacist�</td>\n <td>\n 1</td>\n <td>\n Jimmy Shangalla</td>\n <td>\n Mpharm</td>\n <td>\n 10</td>\n </tr>\n <tr height=\"17\">\n <td height=\"17\" style=\"height:17px;\">\n Data entry clerk</td>\n <td>\n 1</td>\n <td>\n TBA</td>\n <td>\n Diploma�</td>\n <td>\n 8</td>\n </tr>\n <tr height=\"17\">\n <td height=\"17\" style=\"height:17px;\">\n Lab technician�</td>\n <td>\n 1</td>\n <td>\n TBA</td>\n <td>\n Diploma�</td>\n <td>\n 8</td>\n </tr>\n </tbody>\n</table>\n<p>\n �</p>\n
      • other_details_explanation<p>\n The trial is to be conducted in Kenya as the centre is known to be a leading site in conducting clinical trials in Africa. We have the clinical and laboratory capacity to run GCP standard trials. The sponsor is an affiliate of the KEMRI Wellcome Trust Research Programme while the Principal investigator holds a contract with the University of Oxford (the sponsor).</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n Not applicable</p>\n
      • other_details_regulatory_rejected<p>\n Not applicable</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_durationone year
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI Wellcome Trust Research Programme
      • single_site_physical_addressHospital Grounds off Bofa Road
      • single_site_contact_personDr Philip Bejon
      • single_site_telephone+254 41 7522063
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site40
      • total_participants_worldwide230
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameN/A
      • investigator1_middle_name
      • investigator1_family_nameN/A
      • investigator1_qualificationN/A
      • investigator1_professional_addressN/A
      • investigator1_telephoneN/A
      • investigator1_emailpnjuguna@kemri-wellcome.org
      • organisations_transferred_Yes
      • number_participants40
      • notification
      • approval_date08-12-2014
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted12-08-2021
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n BACKGROUND<br />\n The replication-competent recombinant vesicular stomatitis virus (rVSV)–based vaccine<br />\n expressing a Zaire ebolavirus (ZEBOV) glycoprotein was selected for rapid safety and immunogenicity<br />\n testing before its use in West Africa.<br />\n METHODS<br />\n We performed three open-label, dose-escalation phase 1 trials and one randomized,<br />\n double-blind, controlled phase 1 trial to assess the safety, side-effect profile, and immunogenicity<br />\n of rVSV-ZEBOV at various doses in 158 healthy adults in Europe and<br />\n Africa. All participants were injected with doses of vaccine ranging from 300,000 to<br />\n 50 million plaque-forming units (PFU) or placebo.<br />\n RESULTS<br />\n No serious vaccine-related adverse events were reported. Mild-to-moderate early-onset<br />\n reactogenicity was frequent but transient (median, 1 day). Fever was observed in up to<br />\n 30% of vaccinees. Vaccine viremia was detected within 3 days in 123 of the 130 participants<br />\n (95%) receiving 3 million PFU or more; rVSV was not detected in saliva or<br />\n urine. In the second week after injection, arthritis affecting one to four joints developed<br />\n in 11 of 51 participants (22%) in Geneva, with pain lasting a median of 8 days<br />\n (interquartile range, 4 to 87); 2 self-limited cases occurred in 60 participants (3%) in<br />\n Hamburg, Germany, and Kilifi, Kenya. The virus was identified in one synovial-fluid<br />\n aspirate and in skin vesicles of 2 other vaccinees, showing peripheral viral replication<br />\n in the second week after immunization. ZEBOV-glycoprotein–specific antibody responses<br />\n were detected in all the participants, with similar glycoprotein-binding antibody<br />\n titers but significantly higher neutralizing antibody titers at higher doses. Glycoprotein-<br />\n binding antibody titers were sustained through 180 days in all participants.<br />\n CONCLUSIONS<br />\n In these studies, rVSV-ZEBOV was reactogenic but immunogenic after a single dose and<br />\n warrants further evaluation for safety and efficacy. (Funded by the Wellcome Trust and<br />\n others; ClinicalTrials.gov numbers, NCT02283099, NCT02287480, and NCT02296983;<br />\n Pan African Clinical Trials Registry number, PACTR201411000919191.)</p>\n
      • implication_results
      • quantity_imported44
      • quantity_dispensed40
      • quantity_destroyed0
      • quantity_exported0
      • balance_site4
      • final_date0000-00-00
      • modified2021-08-13 10:58:45
      • created2014-11-03 13:50:59
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id239
        • application_id346
        • given_namePhilip
        • middle_name
        • family_nameBejon
        • qualificationPhD
        • professional_addressKEMRI Wellcome Trust Research Programme PO Box 230-80108 Kilifi Kenya
        • telephone+254724445743
        • emailPBejon@kemri-wellcome.org
        • created2014-11-04 10:20:06
        • modified2021-08-12 10:26:46
      • 1(array)
        • id240
        • application_id346
        • given_namePatricia
        • middle_name
        • family_nameNjuguna
        • qualificationMMed
        • professional_addressKEMRI Wellcome Trust Research Programme PO Box 230-80108 Kilifi Kenya
        • telephone+254721833063
        • emailPNjuguna@kemri-wellcome.org
        • created2014-11-04 10:33:18
        • modified2021-08-12 10:26:46
    • SiteDetail(array)
      • 0(array)
        • id291
        • application_id346
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2014-11-04 10:20:06
        • modified2021-08-12 10:26:46
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id183
        • application_id346
        • sponsorUniversity of Oxford
        • sponsor_typeResearch Institution
        • contact_personPhilip Bejon
        • addressKEMRI Wellcome Trust Research Programme, Hospital Grounds Off Bofa Road, PO Box 230 80108, Kilifi, Kenya
        • telephone_number+254 41 7522 063
        • fax_number+254 41 7522 390
        • cell_number+254724445743
        • email_addressPBejon@kemri-wellcome.org
        • created2014-11-04 10:20:06
        • modified2021-08-12 10:26:46
  • 3(array)
    • Application(array)
      • id343
      • user_id32
      • trial_status_id7
      • abstract_of_study<div>\n Artemether-Iumefantrine (AL) was adopted as first-line antimalarial therapy in Kenya in 2006, and dihydroartemisinin-piperaquine (OP) as the second-line therapy in 2010. In order to monitor the efficacy and potential development of resistance of Plasmodium falciparum parasites to these two drugs, we will conduct in-vivo studies to monitor the efficacy of these antimalarial therapies.</div>\n<div>\n  </div>\n<div>\n A standardized World Health Organization (WHO) in-vivo efficacy study will be conducted in western Kenya among children 6-59 months of age with symptomatic, uncomplicated malaria visiting the out-patient department of hospitals and/or clinics in western Kenya.</div>\n<div>\n  </div>\n<div>\n Every two years, 350 children will be randomly aSSigned to be treated with either AL or DP. Clinical, parasitologic, and hematologic parameters will be monitored over a 42-day follow-up period. Molecular analysis will be conducted to determine the frequency of markers of antimalarial resistance, and to differentiate recrudescence from reinfection. Results from this antimalarial drug efficacy study will be used to assist the Kenya national malaria control program (NMCP) in evaluating the national malaria treatment policy.</div>\n
      • study_title<div>\n Open label randomized study evaluating the in vivo efficacies of Artemether-lumefantrine and Dihydroartemisinin-piperaquine in the treatment of uncomplicated Plasmodium falciparum malaria in children under five years of age in western Kenya.</div>\n
      • laymans_summary<div>\n Artemether-Iumefantrine (AL) was adopted as first-line antimalarial therapy in Kenya in 2006, and dihydroartemisinin-piperaquine (OP) as the second-line therapy in 2010. In order to monitor the efficacy and potential development of resistance of Plasmodium falciparum parasites to these two drugs, we will conduct in-vivo studies to monitor the efficacy of these antimalarial therapies.</div>\n<div>\n  </div>\n<div>\n A standardized World Health Organization (WHO) in-vivo efficacy study will be conducted in western Kenya among children 6-59 months of age with symptomatic, uncomplicated malaria visiting the out-patient department of hospitals and/or clinics in western Kenya.</div>\n<div>\n  </div>\n<div>\n Every two years, 350 children will be randomly aSSigned to be treated with either AL or DP. Clinical, parasitologic, and hematologic parameters will be monitored over a 42-day follow-up period. Molecular analysis will be conducted to determine the frequency of markers of antimalarial resistance, and to differentiate recrudescence from reinfection. Results from this antimalarial drug efficacy study will be used to assist the Kenya national malaria control program (NMCP) in evaluating the national malaria treatment policy.</div>\n<div>\n  </div>\n
      • short_titleIn vivo efficacies of AL and DP
      • protocol_noECCT/15/01/05
      • version_no3.0
      • date_of_protocol24-09-2014
      • study_drugArtemether-Lumefantrine & Dihydroartemisinin-Piperaquine
      • disease_conditionMalaria
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameArtemether-Lumefantrine & Dihydroartemisinin-Piperaquine
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresstsang@kemricdc.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd0
      • applicant_prev_data1
      • applicant_stability_data0
      • applicant_analysis_cert0
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter0
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african0
      • applicant_hard_copies(null)
      • applicant_signed_checklist0
      • statistical_analysis_plan0
      • applicant_contractual_agreement0
      • declaration_applicantDr Tony Sang
      • declaration_date130-01-2015
      • declaration_principal_investigatorDr Aaron Samuels, Principle Investigator
      • declaration_date230-01-2015
      • placebo_presentNo
      • study_objectives<div>\n <strong>Objectives</strong></div>\n<div>\n  </div>\n<div>\n i.<span style=\"white-space:pre\"> </span>To measure the clinical and parasitological efficacy of AL and DP among patients aged 6–59 months with symptomatic, uncomplicated P. falciparum malaria,</div>\n<div style=\"margin-left: 40px;\">\n a.<span style=\"white-space:pre\"> </span>Primary efficacy endpoint:  PCR-corrected parasitemia by day 42, the adequate clinical and parsitological response (ACPR)</div>\n<div style=\"margin-left: 40px;\">\n b.<span style=\"white-space:pre\"> </span>Secondary efficacy endpoints:  Determine the proportion of children with early treatment failure (ETF) and  late treatment failure (LTF) by determining the presence of parasitemia on days 3, 7, 14, 28, 35, and 42</div>\n<div style=\"margin-left: 40px;\">\n c.<span style=\"white-space:pre\"> </span>Should funds permit: Assess for delayed parasite clearance and late recrudescence of infection by additionally sampling children with infection densities of ≥10,000 parasites per microliter at 6, 12, 24, and 36 hours post-treatment</div>\n<div>\n ii.<span style=\"white-space:pre\"> </span>To determine the frequency of existing molecular markers for drug resistance and identify new molecular markers</div>\n<div>\n iii.<span style=\"white-space:pre\"> </span>Evaluate drug concentration levels at day 7</div>\n<div>\n iv.<span style=\"white-space:pre\"> </span>Evaluate duration of malaria HRP2/pLDH RDT positivity after appropriate treatment with AL and DP </div>\n<div>\n  </div>\n
      • principal_inclusion_criteria<ol>\n <li>\n Age 6-59 months</li>\n <li>\n Weight ~ 5.0 kg</li>\n <li>\n Axillary temperature ~ 37.52 C or history of fever in the past 24 hours</li>\n <li>\n Hemoglobin ~7 grams/deciliter at enrolment</li>\n <li>\n Slide-confirmed mono-infection with P. jalciparum, with asexual parasitemia (2,000-200,000 asexual parasites/~I)</li>\n <li>\n live within the catchment boundaries of the study site</li>\n <li>\n Ability to swallow oral medication</li>\n <li>\n Ability and willingness to comply with the protocol for the duration of the study</li>\n <li>\n Ability and willingness to comply with the study visit schedule on days 2, 3, 7, 14, 21, 28, 35, and 42</li>\n <li>\n Parent or caregiver has access to a phone so that study staff may contact them during study period for visit reminders</li>\n <li>\n Parent/guardian provides written informed consent</li>\n</ol>\n<div>\n Sub-study inclusion and exclusion criteria - Identical to the main study except:</div>\n<ol>\n <li>\n Parasite density ~10,000 to S200,000</li>\n <li>\n Willingness to be hospitalized for the first 24 hours after ACT treatment</li>\n <li>\n Willingness to follow-up at 36 hrs post-treatment, and on days 2, 3, 7, 14,21,28,35,42</li>\n</ol>\n
      • principal_exclusion_criteria<ol>\n <li>\n Presence of severe malaria or danger signs, including prostration, alteration in level of consciousness, respiratory distress, convulsions, and jaundice</li>\n <li>\n Severe malnutrition according to WHO child growth standards</li>\n <li>\n Known hypersensitivity to any of the drugs being tested</li>\n <li>\n Use of antimalarials or other drugs with antimalarial activity in the last 2 weeks</li>\n <li>\n General clinical condition necessitates hospitalization</li>\n <li>\n Evidence of concomitant infections at the time of presentation</li>\n <li>\n Plan to travel or leave the area within the next 3 months</li>\n <li>\n Have previously been enrolled in this study</li>\n</ol>\n
      • primary_end_points<ul>\n <li>\n treatment failure,</li>\n <li>\n completion of the follow-up period without treatment failure,</li>\n <li>\n loss to follow-up, withdrawal from study (voluntary or involuntary, and protocol violation). loss to follow-up occurs when, despite all reasonable effort, an enrolled patient who does not attend the scheduled visits cannot be found within 3 days oftheir scheduled visit.</li>\n</ul>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety0
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response1
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<table border=\"1\" cellpadding=\"1\" cellspacing=\"1\" style=\"width: 500px;\">\n <tbody>\n <tr>\n <td>\n <strong>Cadre</strong></td>\n <td>\n <strong>Name & Qualification</strong></td>\n </tr>\n <tr>\n <td>\n PI</td>\n <td>\n Aaron Samuels, MD, MSH</td>\n </tr>\n <tr>\n <td>\n PI</td>\n <td>\n Simon Kariuki, PhD</td>\n </tr>\n <tr>\n <td>\n Co-Investigator</td>\n <td>\n Nelli Westercamp, PhD, MPH</td>\n </tr>\n <tr>\n <td>\n Co-Investigator</td>\n <td>\n Meghna Desai, PhD, MPH</td>\n </tr>\n <tr>\n <td>\n Co-Investigator/Lab Manager</td>\n <td>\n Kephas Otieno, MSc,</td>\n </tr>\n <tr>\n <td>\n Pharmacist</td>\n <td>\n Tony Sang, BPharm</td>\n </tr>\n <tr>\n <td>\n Lead Study Nurse</td>\n <td>\n Mary Owidhi</td>\n </tr>\n <tr>\n <td>\n 3 Clinical Officers</td>\n <td>\n  </td>\n </tr>\n <tr>\n <td>\n 3 Nurses</td>\n <td>\n  </td>\n </tr>\n <tr>\n <td>\n 1 Quality Control Officer</td>\n <td>\n  </td>\n </tr>\n <tr>\n <td>\n 3 Laboratory Technologists</td>\n <td>\n  </td>\n </tr>\n <tr>\n <td>\n 2 field workers</td>\n <td>\n  </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_explanation<p>\n N/A</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n Kenya Medical research Institute ERC approved this protocol on 06-Oct-2014</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration6 months
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindYes
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherYes
      • design_controlled_specifyTreatment allocation will be blinded only to the microscopists reading the blood films.
      • design_controlled_comparatorParticipants will be rand
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherYes
      • design_controlled_medicinal_specifyParticipants will be randomised to either receive Artemether-Lumefantrine or Dihydroartemisinin-Piperaquine
      • single_site_member_stateYes
      • location_of_areaSiaya District Hospital
      • single_site_physical_addressSiaya
      • single_site_contact_personSimon Kariuki
      • single_site_telephone0725 389246
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site350 participants in total every two years
      • total_participants_worldwide350 participants every two years
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentNo
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyChildren under 5 will be enrolled upon consent given by parent or guardian
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameAaron
      • investigator1_middle_name
      • investigator1_family_nameSamuels
      • investigator1_qualificationMD, MHS(CDC)
      • investigator1_professional_address1600 Clifton Road NE, MIS A06 Atlanta, Georgia 30329
      • investigator1_telephone+1 (404) 718-4779 or 0727 037873
      • investigator1_emailiyp2@cdc.gov
      • organisations_transferred_No
      • number_participants350 participants every two years
      • notification
      • approval_date03-03-2015
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted02-10-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe study has been approved
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2020-10-02 13:12:43
      • created2014-10-29 10:01:58
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id237
        • application_id343
        • given_nameAAron
        • middle_name
        • family_nameSamuels
        • qualificationMD, MHS(CDC)
        • professional_address1600 Clifton Road NE, MIS A06 Atlanta, Georgia 30329
        • telephone+1 (404) 718-4779 or 0727 037873
        • emailiyp2@cdc.gov
        • created2014-10-29 10:06:39
        • modified2020-10-02 13:12:43
      • 1(array)
        • id238
        • application_id343
        • given_nameSimon
        • middle_name
        • family_nameKariuki
        • qualificationPhD
        • professional_address1578-40100 Kisumu, Kenya
        • telephone0725 389 246
        • emailskariuki@kemricdc.org
        • created2014-10-29 10:13:28
        • modified2020-10-02 13:12:43
    • SiteDetail(array)
      • 0(array)
        • id290
        • application_id343
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2014-10-29 10:06:39
        • modified2020-10-02 13:12:43
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id182
        • application_id343
        • sponsorKenya Medical Research Institute
        • sponsor_typeResearch Institution
        • contact_personDr Simion Kariuki
        • address1578-40100 Kisumu Kenya
        • telephone_number+254 57 2022902/29
        • fax_number
        • cell_number+254 725 389 246
        • email_addressskariuki@kemricdc.org
        • created2014-10-29 10:06:39
        • modified2020-10-02 13:12:43
  • 4(array)
    • Application(array)
      • id332
      • user_id217
      • trial_status_id(null)
      • abstract_of_study<p>\n <strong><u>ABSTRACT</u></strong></p>\n<p>\n Assessment of safety and efficacy of BroZedex syrup in the treatment of productive cough</p>\n<p>\n Phase 111 Randomized Placebo Controlled Parallel Multicentre Study.</p>\n<p>\n Acute bronchitis, acute exacerbations of chronic bronchitis, pneumonia and asthmatic bronchitis are often associated with productive cough.  Treatment of cough associated with expectoration is best accomplished by syrup that includes a mucolytic expectorant and probably a bronchodilator as well.</p>\n<p>\n BroZedex syrup includes terbulatine sulphate a direct acting β2 receptor agonist, guaiphenesin an expectorant, Bromhexine a mucolytic and menthol a soothing agent. Terbutaline alleviates bronchospasm due to relaxation of bronchial smooth muscles leading to easier breathing by dilating airways. Bromhexine hydrochloride is a mucolytic and mucokinetic agent.  It reduces sputum viscosity. Guaiphenesin is an expectorant that acts by enhancing respiratory fluid output.  This increases the volume of secretions on respiratory tract to facilitate sputum removal.  Menthol acts as a demulcent and soothing agent.</p>\n<p>\n This study proposes to demonstrate safety and efficacy of BroZedex in the treatment of productive cough associated with above conditions in our population.  The study will be conducted in three sites in Nairobi and 184 patients will be enrolled in the study.</p>\n<p>\n The study patients will be put on either BroZedex or Placebo based on study number and allocated product based on computer generated randomization code.</p>\n<p>\n The medication will be taken for 7 days and there will be three visits for the patients, day 1, 3 and 7. Subject assessment will be based on sputum consistency, severity of cough from baseline to end of study using a 4 point scale, onset of cough relief post first dose, change in breathlessness, volume of sputum, frequency of bouts of coughing, symptomatic relief rating daytime and night time cough score, and investigators and patients clinical global impression of change.</p>\n<p>\n Patients will be given a subject diary for recording of assessed parameter.  All patients will be evaluated for vital signs when they undergo physical examination at all study visits.</p>\n<p>\n The study will be conducted with the permission of IRB’s of KEMRI and Kenyatta National Hospital.  The study will be performed, respecting international and national ethical guidelines and after obtaining informed consent from each patient/parent/guardian.  Data generated will potentially inform on the safety and effectiveness of Bro-Zedex in the symptomatic management of productive cough in our population.</p>\n
      • study_title<p>\n <strong>Assessment of Safety and Efficacy of Brozedex Syrup in the Treatment of Productive Cough. Phase III, Randomized, Double Blind, Placebo-Controlled, Parallel Group and Multi-Site Study Conducted In Nairobi in three sites </strong></p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/14/09/04
      • version_noVersion 5
      • date_of_protocol23-06-2014
      • study_drugBro-Zedex
      • disease_conditionCough
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameTerbutaline Sulfate BP, Chlorhydrate Bromhexine BP, Guaifenesine BP (Bro-Zedex)
      • product_type_medical_device_nameNone
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressjomamo@kemri.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantJemima Omamo
      • declaration_date128-10-2014
      • declaration_principal_investigatorDr. Hudson A. Lodenyo
      • declaration_date228-10-2014
      • placebo_presentYes
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n Patients <strong>must</strong> meet <u>all</u> of the following criteria:</p>\n<ol>\n <li>\n Male and female patients aged ≥ 3 years to 65 years.</li>\n <li>\n Subjects experiencing symptomatic cough due to common cold for at least 1 day and not longer than 5 days prior to enrolment. Severity score to be mild to moderate. (<strong>mild: </strong>didn’t interfere with usual morning or daily activity; <strong>moderate: </strong>must stop activity during coughing episodes).</li>\n <li>\n Subjaects with onset of productive cough not more than2 days prior to enrolment.</li>\n <li>\n Subject/Parents/Guardians who understand the nature of the study and provide written informed consent.</li>\n <li>\n <strong>Must not be on any other syrup used to suppress/modify cough</strong></li>\n</ol>\n
      • principal_exclusion_criteria<p>\n Patients who meet <strong>ANY</strong> of the following exclusion criteria will <strong>NOT</strong> be eligible for enrolment:</p>\n<ol>\n <li>\n Subjects with proven hypersensitivity to the sympathomimetic amines or other components of investigational product.</li>\n</ol>\n<p>\n  </p>\n<ol>\n <li value=\"2\">\n Subjects suffering from thyrotoxicosis, peptic ulcers or having bleeding problems.</li>\n <li>\n Subjects experiencing acute symptoms of respiratory allergies, a history of chronic respiratory illness, or had a significant coexisting illness or medical condition that would compromise their ability to swallow, absorb, metabolize or excrete the investigational product</li>\n <li>\n Subjects would be excluded from the study if they have taken any medications/supplements within the 24 hours prior to inclusion in the study that are indicated for cold symptoms or that could produce drowsiness or promote alertness, taken any antihistamines within the previous 72 hours, taken any sedatives within the previous week, or taken any antidepressants within the previous 3 weeks.</li>\n <li>\n Subjects who are regular users of neuroleptics, sedative, hypnotics, tranquillizers, psychotropic active substances or any other addictive agents</li>\n <li>\n Subjects with clinically relevant gynecological, cardiovascular (arrhythmia), hematologic, hepatic (damage), gastrointestinal, renal, pulmonary, endocrinologic (uncontrolled diabetes mellitus), neurologic or psychiatric disease, based on a PI discretion</li>\n <li>\n Subjects with history or evidence of acute or chronic alcohol abuse</li>\n <li value=\"8\">\n Subjects who is pregnant (as confirmed by a urine pregnancy test) or is currently breast-feeding.</li>\n <li value=\"9\">\n Employee of the Investigator, or a patient who has a direct involvement with the trial or other trials under the direction of the Investigator.</li>\n <li value=\"10\">\n Has been treated with other investigational agent or devices within the previous 30 days, has planned use of investigational drugs or devices, or has been previously screened in this trial.</li>\n</ol>\n
      • primary_end_points<ul>\n <li>\n Frequency of bouts of coughing</li>\n <li>\n Symptomatic relief rating pre and post-dose</li>\n</ul>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n Principal Investigator Dr. Hudson A. Lodenyo</p>\n<p>\n Associate Investigator: Dr. Evans Amukoye</p>\n<p>\n Study Coodinator: Jemima Omamo</p>\n<p>\n Clinical Monitor: Barbara Miheso</p>\n<p>\n Clinical Officers: 1. Caroline Epiche</p>\n<p>\n                          2. Joseph Mulusa</p>\n<p>\n                          3. Alex Njuguna</p>\n<p>\n Field Workers ; 1. Winnie Chepkirui</p>\n<p>\n                        2. Susan Masila</p>\n<p>\n                        3.Jeniffer Naikuni</p>\n<p>\n Lab Technologist: Lucas Agura (Coordinator Work)</p>\n<p>\n  </p>\n<p>\n SIte Facilities: Clinics at Mbagathi Hospital,Rhodes Chest Clinic and Mama Lucy Kibaki where patient recruitment and follow up will take place. Incase of emergencies the paatiets will be seen at the same facilities.</p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n N/A</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n KEMRI Ethical Review Committee dated 30th June 2014. 3 sitesin Nairobi</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration4 - 6 months depending on speed of recruitment.
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPhase III Randomised, Dou
      • design_controlled_other_medicinalYes
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sitesThree (3) sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site92
      • total_participants_worldwide252
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameDr. Evans
      • investigator1_middle_nameInyangala
      • investigator1_family_nameAmukoye
      • investigator1_qualificationMBChB M.Med (Ped)
      • investigator1_professional_addressBox 61877, Nairobi 00200 Kenya
      • investigator1_telephone+254722634383
      • investigator1_emailamukoye@gmail.com
      • organisations_transferred_No
      • number_participants239
      • notification
      • approval_date09-12-2014
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted28-10-2014
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2014-12-09 12:32:48
      • created2014-09-24 08:34:34
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id234
        • application_id332
        • given_nameHudson
        • middle_nameAubrey
        • family_nameLodenyo
        • qualificationMBChB M.Med
        • professional_addressBox 54840, Nairobi 00200 Kenya
        • telephone+254722621052
        • emaillodenyoh@gmail.com
        • created2014-09-24 08:46:47
        • modified2014-10-28 10:35:12
    • SiteDetail(array)
      • 0(array)
        • id284
        • application_id332
        • county_id47
        • site_nameRhodes Clinic/Ngaira Health Centre
        • physical_addressHaile Selassie Avenue, Next to Kenya Polytechnic, Nairobi
        • contact_detailsDr. Muthongo, Box 30108, Nairobi 00100
        • contact_personMr. Joseph Mulusa
        • site_capacity(null)
        • misc(null)
        • created2014-09-24 08:46:47
        • modified2014-10-28 10:35:12
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id286
        • application_id332
        • county_id47
        • site_nameMbagathi District Hospital
        • physical_addressOff Mbagathi Way, Box 20725, Nairobi 00202
        • contact_detailsDr. Andrew Sule, Hospital Superintendant
        • contact_personMs. Caroline Epiche
        • site_capacity(null)
        • misc(null)
        • created2014-10-02 12:14:55
        • modified2014-10-28 10:35:12
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 2(array)
        • id287
        • application_id332
        • county_id47
        • site_nameMama Lucy Hospital
        • physical_addressKayole Area, Box 1278 -00515, Nairobi
        • contact_detailsDr. Julius Ogato - Medical Superintendent
        • contact_personMr. Alex Juguna
        • site_capacity(null)
        • misc(null)
        • created2014-10-02 12:14:55
        • modified2014-10-28 10:35:12
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id180
        • application_id332
        • sponsorWockhardt Limited
        • sponsor_type(null)
        • contact_personGaurav Yashwanttrao Puppalwar
        • addressD-18 West, 8th Level, Wockhardt Towers, Wockhardt Ltd, Bandra-Kurla Complex, Bandra (E), Mumbai (India) - 400 051
        • telephone_number+912226534444
        • fax_number+912226534242
        • cell_number+919167375763
        • email_addressgpuppalwar@wockhardt.com
        • created2014-09-24 08:46:47
        • modified2014-10-28 10:35:12
• page_options(array)
  • 55
  • 1010
• redir
• $request->data(array)
  • Application(array)
    • approved2
• $this->validationErrors(array)
  • Permission(empty)
  • Aro(empty)
  • Aco(empty)
  • Application(empty)
  • User(empty)
  • TrialStatus(empty)
  • InvestigatorContact(empty)
  • Sponsor(empty)
  • SiteDetail(empty)
  • County(empty)
• Loaded Helpers(array)
  • 0Html
  • 1Form
  • 2Session
  • 3Text
  • 4Number
  • 5SimpleGraph
  • 6Paginator
  • 7DebugTimer
  • 8Toolbar
  • 9HtmlToolbar

App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

• 0/var/www/html/ctr/app/Plugin/Media/Lib/mm/src
• 1/var/www/html/ctr/lib
• 3/usr/share/php
• 4-> /var/www/html/ctr/lib/Cake/

Included Files

• core(array)
  • Behavior(array)
    • 0CORE/Model/Behavior/TreeBehavior.php
    • 1CORE/Model/Behavior/ContainableBehavior.php
    • 2CORE/Model/Behavior/AclBehavior.php
  • Cache(array)
    • 0CORE/Cache/Cache.php
    • 1CORE/Cache/Engine/FileEngine.php
    • 2CORE/Cache/CacheEngine.php
  • Component(array)
    • 0CORE/Controller/Component/AclComponent.php
    • 1CORE/Controller/Component/Acl/DbAcl.php
    • 2CORE/Controller/Component/Acl/AclInterface.php
    • 3CORE/Controller/Component/AuthComponent.php
    • 4CORE/Controller/Component/RequestHandlerComponent.php
    • 5CORE/Controller/Component/SessionComponent.php
    • 6CORE/Controller/Component/PaginatorComponent.php
  • Config(array)
    • 0CORE/Config/routes.php
    • 1CORE/Config/config.php
  • Controller(array)
    • 0CORE/Controller/Controller.php
    • 1CORE/Controller/ComponentCollection.php
    • 2CORE/Controller/Component.php
  • Datasource(array)
    • 0CORE/Model/Datasource/CakeSession.php
    • 1CORE/Model/Datasource/Database/Mysql.php
    • 2CORE/Model/Datasource/DboSource.php
    • 3CORE/Model/Datasource/DataSource.php
  • Error(array)
    • 0CORE/Error/exceptions.php
    • 1CORE/Error/ErrorHandler.php
  • I18n(array)
    • 0CORE/I18n/I18n.php
    • 1CORE/I18n/L10n.php
  • Log(array)
    • 0CORE/Log/CakeLog.php
    • 1CORE/Log/LogEngineCollection.php
    • 2CORE/Log/Engine/FileLog.php
    • 3CORE/Log/Engine/BaseLog.php
    • 4CORE/Log/CakeLogInterface.php
  • Model(array)
    • 0CORE/Model/ConnectionManager.php
    • 1CORE/Model/Permission.php
    • 2CORE/Model/Model.php
    • 3CORE/Model/BehaviorCollection.php
    • 4CORE/Model/Aro.php
    • 5CORE/Model/AclNode.php
    • 6CORE/Model/Aco.php
    • 7CORE/Model/ModelBehavior.php
  • Network(array)
    • 0CORE/Network/CakeRequest.php
    • 1CORE/Network/CakeResponse.php
  • Other(array)
    • 0CORE/bootstrap.php
    • 1CORE/basics.php
    • 2CORE/Core/App.php
    • 3CORE/Core/Configure.php
    • 4CORE/Core/CakePlugin.php
    • 5CORE/Event/CakeEventListener.php
    • 6CORE/Event/CakeEvent.php
    • 7CORE/Event/CakeEventManager.php
    • 8CORE/Core/Object.php
  • Routing(array)
    • 0CORE/Routing/Dispatcher.php
    • 1CORE/Routing/Filter/AssetDispatcher.php
    • 2CORE/Routing/DispatcherFilter.php
    • 3CORE/Routing/Filter/CacheDispatcher.php
    • 4CORE/Routing/Router.php
    • 5CORE/Routing/Route/CakeRoute.php
    • 6CORE/Routing/Route/PluginShortRoute.php
  • Utility(array)
    • 0CORE/Utility/Hash.php
    • 1CORE/Utility/Inflector.php
    • 2CORE/Utility/ObjectCollection.php
    • 3CORE/Utility/Debugger.php
    • 4CORE/Utility/String.php
    • 5CORE/Utility/ClassRegistry.php
    • 6CORE/Utility/Set.php
    • 7CORE/Utility/Sanitize.php
  • View(array)
    • 0CORE/View/HelperCollection.php
• app(array)
  • Behavior(array)
    • 0APP/Model/Behavior/SoftDeleteBehavior.php
  • Config(array)
    • 0APP/Config/core.php
    • 1APP/Config/bootstrap.php
    • 2APP/Config/routes.php
    • 3APP/Config/database.php
  • Controller(array)
    • 0APP/Controller/ApplicationsController.php
    • 1APP/Controller/AppController.php
  • Model(array)
    • 0APP/Model/AppModel.php
    • 1APP/Model/Application.php
    • 2APP/Model/User.php
    • 3APP/Model/TrialStatus.php
    • 4APP/Model/InvestigatorContact.php
    • 5APP/Model/Sponsor.php
    • 6APP/Model/SiteDetail.php
    • 7APP/Model/County.php
  • Other(array)
    • 0APP/webroot/index.php
• plugins(array)
  • CakePdf(array)
    • Config(array)
      • 0CakePdf/Config/bootstrap.php
      • 1CakePdf/Config/routes.php
  • CakeResque(array)
    • Config(array)
      • 0CakeResque/Config/bootstrap.php
    • Plugin(array)
      • 0CakeResque/Lib/CakeResque.php
      • 1CakeResque/vendor/kamisama/php-resque-ex/lib/Resque.php
      • 2CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Event.php
      • 3CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Exception.php
  • DebugKit(array)
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    • Plugin(array)
      • 0DebugKit/Lib/DebugMemory.php
      • 1DebugKit/Lib/Panel/HistoryPanel.php
      • 2DebugKit/Lib/DebugPanel.php
      • 3DebugKit/Lib/Panel/SessionPanel.php
      • 4DebugKit/Lib/Panel/RequestPanel.php
      • 5DebugKit/Lib/Panel/SqlLogPanel.php
      • 6DebugKit/Lib/Panel/TimerPanel.php
      • 7DebugKit/Lib/Panel/LogPanel.php
      • 8DebugKit/Lib/Log/Engine/DebugKitLog.php
      • 9DebugKit/Lib/Panel/VariablesPanel.php
      • 10DebugKit/Lib/Panel/EnvironmentPanel.php
      • 11DebugKit/Lib/Panel/IncludePanel.php
      • 12DebugKit/Lib/DebugTimer.php
  • Media(array)
    • Config(array)
      • 0Media/Config/bootstrap.php
    • Plugin(array)
      • 0Media/Lib/mm/src/Mime/Type.php
      • 1Media/Lib/mm/src/Mime/Type/Magic/Adapter/Fileinfo.php
      • 2Media/Lib/mm/src/Mime/Type/Magic/Adapter.php
      • 3Media/Lib/mm/src/Mime/Type/Glob/Adapter/Memory.php
      • 4Media/Lib/mm/src/Mime/Type/Glob/Adapter.php
      • 5Media/Lib/mm/src/Media/Process.php
      • 6Media/Lib/mm/src/Media/Info.php
  • Search(array)
    • Component(array)
      • 0Search/Controller/Component/PrgComponent.php
    • Behavior(array)
      • 0Search/Model/Behavior/SearchableBehavior.php
  • Shim(array)
    • Config(array)
      • 0Shim/Config/bootstrap.php
  • Tools(array)
    • Config(array)
      • 0Tools/Config/bootstrap.php