NCT03967054

Repeat Ivermectin Mass Drug Administrations for MALaria Control II

Repeat Ivermectin Mass Drug Administrations for MALaria Control II (RIMDAMAL II): a Double-blind, Cluster-randomized Control Trial for Integrated Control of Malaria

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,124 (actual)
• Sponsor: Brian Foy · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Malaria

Interventions

Type	Name	Description
DRUG	Ivermectin	Ivermectin (6 mg tablet) given monthly from July-October each rainy season as a 3-day course of approximately 300 mcg/kg/day as estimated by height bands.
DRUG	Placebo oral tablet	placebo in the same size, color and shape at the ivermectin tablet

Timeline

• Start date: 2019-07-13
• Primary completion: 2020-11-08
• Completion: 2024-08-01
• First posted: 2019-05-30
• Last updated: 2025-04-10
• Results posted: 2024-01-11

Locations

1 site across 1 country: Burkina Faso