Repeat Ivermectin Mass Drug Administrations for Control of Malaria: a Pilot Safety and Efficacy Study

Phase 2/3 Completed 2712 enrolled Colorado State University Centre Muraz · collab Institut de Recherche en Sciences de la Sante, Burkina Faso · collab Ministère de la Santé du Burkina Faso · collab

RandomizedParallel-groupSingle-blindTreatment

Summary

The purpose of this study is to determine whether repeated ivermectin mass drug administrations to Burkinabé villagers, performed in three week intervals over the rainy-season, is well-tolerated and safe, and also effective in reducing local malaria transmission and thus clinical malaria episodes in treated village children.

Timeline

Start: 2015-06
Primary completion: 2015-11
Completion: 2015-12

Outcome

Met primary endpoint

paper Cumulative malaria incidence was reduced in the intervention group (648 episodes among 327 children; estimated mean 2·00 episodes per child) compared with the control group PMID 30878222 ↗

paper risk difference -0·49 [95% CI -0·79 to -0·21], p=0·0009, adjusted for sex and clustering. PMID 30878222 ↗

Publications

Foy BD, Alout H, Seaman JA, Rao S, Magalhaes T, Wade M, Parikh S, Soma DD, Sagna AB, Fournet F, Slater HC, Bougma R, Drabo F, Diabate A, Coulidiaty AGV, Rouamba N, Dabire RK. Efficacy and risk of harms of repeat ivermectin mass drug administrations for control of malaria (RIMDAMAL): a cluster-randomised trial. Lancet. 2019 Apr 13;393(10180):1517-1526. doi: 10.1016/S0140-6736(18)32321-3. Epub 2019 Mar 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ivermectin	Small molecule	150 ug/kg	Oral
Background	Albendazole	Small molecule	400 mg	Oral