Worms are a group of parasites that cause major disease burden worldwide. The World  Health Organization (WHO) estimates that 1.5 billion people are infected with at least one of  the four types of worms. WHO guidelines have called for controlling worms by preventive  treatment through mass drug administration of a deworming drug known as albendazole or mebendazole – mainly to preschool-aged children, school-aged children and women of reproductive age. However, one can still catch worms again after being treated and the  deworming drugs currently used could be ineffective for some types of worms so a new based on the multicenter protocol 2.0, 7th March 2024 Page 11 of 69 combination of drugs and dosing strategy is needed. The aim of this study is to test whether a combination of two deworming drugs, albendazole and ivermectin is safe and works better  than albendazole alone via mass drug administration to school-aged children. A total of 20,000 (around 10,000 in Kenya) eligible participants (meeting the following criteria: aged 5  to 17 years old, height over 90 cm, parental acceptance to participate in the study by written informed consent [and a written assent from children 12-17 years old] and the absence of risk of being infected by a type of worm called Loa loa (eye worm), serious medical illness, any condition that prevents the appropriate evaluation and follow-up of the participant per the  investigator’s criteria, known hypersensitivity (allergic reaction) to any component of either  study treatment and pregnancy or first week post-partum [period after childbirth] reported by  the participant during interview) will be enrolled. In Kenya, the study will be conducted in  primary schools in Mkongani and Ramisi wards, Kwale county. A minimum of 15 schools will be enrolled per treatment arm. Based on the list of available schools in the selected areas, only schools with 200-600 children will qualify for potential participation in the trial. Enrolled  participants will receive a single dose of the combined albendazole-ivermectin or albendazole  alone and will be visited in school by a study doctor on the day of treatment (day 0), day one, day two and day seven after treatment to look for any undesired effects of the treatment or change in a pre-existing condition. Adverse events will also be monitored though passive  surveillance in sentinel health facilities. A proportion of 75 children in each participating school will be asked to provide a stool sample before getting the treatment, 21 days after the  treatment (± 7 days) and 11 months after treatment (± 28 days). The same child will be asked  to provide a blood drop sample collected through a finger prick before treatment and at 11 months after treatment (± 28 days). Results of this study could provide very useful information  about the importance of combining existing deworming drugs to provide safe and better treatment option against worm infections.  

Soil-transmitted helminths (STH) are a group of parasitic worms that cause a major  cumulative disease burden worldwide. The World Health Organization (WHO) estimates that 1.5 billion people are infected with at least one of four STH species, including Ascaris  lumbricoides, Trichuris trichiura, and the two hookworms, Necator americanus and Ancylostoma duodenale. WHO guidelines for STH have called for controlling morbidity by  preventive chemotherapy through mass drug administration (MDA) of the benzimidazole- class anthelmintics –albendazole or mebendazole – mainly to preschool-aged children, school-aged children and women of reproductive age. However, benzimidazole-based MDA is not equally effective against all STH, with lower (and decreasing) efficacy against T. trichiura. Given this situation, there is a pressing need to identify regimens with improved efficacy and provide evidence for the revision of the current preventive chemotherapy  strategy if transmission interruption goals are to be achieved. This study aims to evaluate and compare the safety and effectiveness of a fixed dose co-formulation (FDC) of albendazole-ivermectin against Albendazole via mass drug administration in a Multi-centric,  randomized by school, two-arm, parallel, open-label, pragmatic trial. A total of around 20,000 (around 10,000 in Kenya) eligible participants will be enrolled. In Kenya, the study will be conducted in primary schools in Mkongani and Ramisi wards, Kwale county. A minimum of 15 schools will be enrolled per treatment arm. Based on the list of available schools in the  selected areas, only schools with 200-600 children will qualify for potential participation in the  trial. All participants included in the list of eligible participants from a particular randomized  school will receive a single dose of the medication administered to their school (fixed dose  co-formulation [FDC] or albendazole). Enrolled participants will be visited in school by a study physician on the day of intervention (day 0), day one, day two and day seven after intervention  to look for any potential adverse events or change in a pre-existing condition. Adverse events will also be monitored though passive surveillance in sentinel health facilities. A proportion of 75 children in each participating school will be asked to provide a stool sample before getting the intervention, 21 days after the intervention (± 7 days) and 11 months after intervention (± 224 28 days). The same child will be asked to provide a blood drop sample collected through a finger prick before intervention and at 11 months after intervention (± 28 days).  events for fixed dose co-formulation (FDC) and Albendazole. Results of this study could provide invaluable information about the use of combination therapy with existing drugs  against neglected tropical diseases which has been identified as a strategy that could offer a  solution to the lack of investment by the pharmaceutical industry for the development of new  therapeutic agents