| Protocol No: | ECCT/15/01/05 | Date of Protocol: | 24-09-2014 |
| Study Title: |
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.
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| Study Objectives: |
Objectives
i. To measure the clinical and parasitological efficacy of AL and DP among patients aged 6–59 months with symptomatic, uncomplicated P. falciparum malaria,
a. Primary efficacy endpoint: PCR-corrected parasitemia by day 42, the adequate clinical and parsitological response (ACPR)
b. 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
c. 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
ii. To determine the frequency of existing molecular markers for drug resistance and identify new molecular markers
iii. Evaluate drug concentration levels at day 7
iv. Evaluate duration of malaria HRP2/pLDH RDT positivity after appropriate treatment with AL and DP
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| Laymans Summary: |
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.
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.
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.
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| Abstract of Study: |
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.
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.
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.
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