Repeat Ivermectin Mass Drug Administrations for MALaria Control II

• Status: Active, not recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Brian Foy
• Collaborators: Institut de Recherche en Sciences de la Sante; PATH; Radboud University; Yale University
• Treatments: Ivermectin

Criteria

Inclusion Criteria (for being enrolled in the study):

• Residence in selected study village

• Able to understand the information and willing to give consent or assent (age 12-18) and parent/guardian consent if study participant age is < 18 years of age.

Exclusion Criteria (for participating in the intervention [ivermectin or placebo MDA]):

• Residence outside of the study village

• Height < 90 cm (*note: if subject becomes ≥90cm over course the trial, this exclusion criteria will no longer be valid in subsequent MDA)

• Current treatment with SP+AQ as part of SMC (restricted to children 3-59 months old) (*note: if subject discontinuous SP+AQ treatment because they become older than 59 months over course the trial, this exclusion criteria will no longer be valid in subsequent MDA)

• Permanent disability or serious medical illness that prevents or impedes study participation and/or comprehension

• Pregnancy (screened for in women of child-bearing age [ages 15-45] using a pregnancy urine rapid test [e.g. SD Bioline hCG] the week prior to each MDA)

• Breast feeding if infant is within 1 week of birth

• Known allergy to ivermectin

• Possibility of Loa loa infection as assessed by travel history to Angola, Cameroon, Chad, Central African Republic, Congo, Democratic Republic of Congo, Equatorial Guinea, Ethiopia, Gabon, Nigeria, and Sudan.

• Enrolled in any other active clinical trials