Repeat Ivermectin Mass Drug Administrations for MALaria Control II

NCT03967054 | Completed Phase 3 Results DMC

• 2 other identifiers: 1691U01AI138910
• Study Type: interventional
• Target: 4,124
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria

Keywords

mosquito; ivermectin; Anopheles; Plasmodium

Outcome Measures

Primary Outcomes (1)

• Malaria Incidence

  Incidence of malaria episodes in enrolled village children ≤ 10 years of age

  up to 8 months

Secondary Outcomes (2)

• Adverse Events

  up to 8 months

• Survival Rate of Blood Fed Mosquitoes

  up to 8 months

Study Arms (2)

Ivermectin mass drug administration

EXPERIMENTAL

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.

Drug: Ivermectin

Placebo mass administration

PLACEBO COMPARATOR

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.

Drug: Placebo oral tablet

Interventions

Ivermectin DRUG

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.

Also known as: Iver P

Ivermectin mass drug administration

Placebo oral tablet DRUG

placebo in the same size, color and shape at the ivermectin tablet

Placebo mass administration

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Residence outside of the study village
• 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

Sponsors & Collaborators

• Brian Foy: lead
• Yale University: collaborator
• Institut de Recherche en Sciences de la Sante-Direction Regionale de l'Ouest: collaborator
• Radboud University Medical Center: collaborator
• PATH: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Institut de Recherche en Sciences de la Sante

Diébougou, Sud-Ouest Region, Burkina Faso

Location

Related Publications (2)

• Some AF, Some A, Sougue E, Ouedraogo COW, Da O, Dah SR, Nikiema F, Magalhaes T, Gray LI, Finical W, Pugh G, Lado P, Randall JC, Burton TA, Ring ME, Leon AS, Colt M, Li F, Wang K, Wade M, Lier AJ, Richards K, Sproch H, Zhang E, Ellman J, Achebe I, Jackson CL, Xiao M, Wu EJ, Bousema T, Slater HC, Foy BD, Parikh S, Dabire RK. Safety and efficacy of repeat ivermectin mass drug administrations for malaria control (RIMDAMAL II): a phase 3, double-blind, placebo-controlled, cluster-randomised, parallel-group trial. Lancet Infect Dis. 2025 Jul;25(7):737-750. doi: 10.1016/S1473-3099(24)00751-5. Epub 2025 Feb 4.

  PMID: 39919778 DERIVED

• Foy BD, Some A, Magalhaes T, Gray L, Rao S, Sougue E, Jackson CL, Kittelson J, Slater HC, Bousema T, Da O, Coulidiaty AGV, Colt M, Wade M, Richards K, Some AF, Dabire RK, Parikh S. Repeat Ivermectin Mass Drug Administrations for Malaria Control II: Protocol for a Double-blind, Cluster-Randomized, Placebo-Controlled Trial for the Integrated Control of Malaria. JMIR Res Protoc. 2023 Mar 20;12:e41197. doi: 10.2196/41197.

  PMID: 36939832 DERIVED

MeSH Terms

Conditions

Malaria

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Brian D. Foy, PhD.
• Organization: Colorado State University

Brian.Foy@colostate.edu

970-491-3470

Study Officials

• Brian D. Foy, PhD

  Colorado State University

  PRINCIPAL INVESTIGATOR

• Sunil Parikh, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study pharmacist in charge of the drug stock room will originate the masking and maintain the masking from all other investigators. The masking codes will be written on three paper copies and put in identical and sealed opaque envelopes, which will be kept in three different areas.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Parallel-assignment trial with two arms randomized in a 1:1 ratio.

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: May 30, 2019
• Study Start: July 13, 2019
• Primary Completion: November 8, 2020
• Study Completion: August 1, 2024
• Last Updated: April 10, 2025
• Results First Posted: January 11, 2024

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Within 6 mos of publication of the primary outcomes of the study.

Locations

BU (1)