Repeat Ivermectin Mass Drug Administrations for MALaria Control II
- Registration Number
- NCT03967054
- Lead Sponsor
- Brian Foy
- Brief Summary
RIMDAMAL II is a double-blind, cluster randomized trial in Burkina Faso designed to test whether repeated ivermectin mass drug administrations, integrated into a monthly delivery platform with standard malaria control measures of seasonal malaria chemoprevention and insecticide-treated bed net distribution in the Sahel, will reduce childhood malaria incidence.
- Detailed Description
The RIMDAMAL II trial is designed to determine the efficacy of adding seasonal ivermectin mass drug administrations to the standard-policy malaria control measures in the Sahel (seasonal malaria chemoprevention in children, maximum long-lasting insecticidal net coverage, intermittent preventive treatment in pregnancy), for reducing the incidence of uncomplicated malaria episodes in enrolled village children (≤ 10 years of age) assessed by active case surveillance. The investigators will also examine the safety of the intervention, as well as entomological and parasitological endpoints. This is a double-blind, cluster randomized trial in that will occur in villages in southwestern Burkina Faso over two consecutive rainy seasons. For the intervention, mass administration of ivermectin or placebo will be given monthly over 4 months of each rainy season to the eligible village population, each as 3-day course of 300 µg/kg/day. These mass drug administrations will occur simultaneously with the distribution of seasonal malaria chemoprevention drugs on the same monthly schedule to eligible children aged 3-59 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4124
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo mass administration Placebo oral tablet Placebo given monthly from July-October (4 times) as a 3-day course to all eligible persons per exclusion/inclusion criteria. Dosing of placebo will be according to height to approximate weight: 90-119 cm = 1 tablet/day for 3 days; 120-140 cm = 2 tablets/day for 3 days; 141-158 cm = 3 tablets/day for 3 days; \>158 cm = 4 tablet/day for 3 days. Ivermectin mass drug administration Ivermectin Ivermectin given monthly from July-October (4 times) as a 3-day course of 300 µg/kg/day to all eligible persons per exclusion/inclusion criteria. Per package insert, dosing of IVM will be according to height to approximate weight: 90-119 cm = 1 tablet/day for 3 days; 120-140 cm = 2 tablets/day for 3 days; 141-158 cm = 3 tablets/day for 3 days; \>158 cm = 4 tablet/day for 3 days.
- Primary Outcome Measures
Name Time Method Malaria Incidence up to 8 months Incidence of malaria episodes in enrolled village children ≤ 10 years of age
- Secondary Outcome Measures
Name Time Method Adverse Events up to 8 months Number adverse events among the study population over the course of the intervention period. Note, this number includes all malaria cases that were part of the primary outcome that occurred in the cohort of children that were actively assessed for malaria on a weekly basis during the intervention.
Survival Rate of Blood Fed Mosquitoes up to 8 months Number of Blood Fed Mosquitoes Alive For 3 Days After Capture
Trial Locations
- Locations (1)
Institut de Recherche en Sciences de la Sante
🇧🇫Diebougou, Sud-Ouest, Burkina Faso