Repeat Ivermectin Mass Drug Administrations for MALaria Control II (RIMDAMAL II)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Malaria
• Intervention / Treatment: Drug: Ivermectin; Drug: Placebo oral tablet

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.

• Study Type: Interventional
• Enrollment (Actual): 4124
• Phase: Phase 3

Contacts and Locations

Study Locations

• Burkina Faso
  • Sud-Ouest
    • Diebougou, Sud-Ouest, Burkina Faso
      • Institut de Recherche en Sciences de la Santé

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ivermectin mass drug administration; 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; 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.; Other Names: Iver P
Placebo Comparator: Placebo mass administration; 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; placebo in the same size, color and shape at the ivermectin tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Malaria Incidence	Incidence of malaria episodes in enrolled village children ≤ 10 years of age	up to 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	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.	up to 8 months
Survival Rate of Blood Fed Mosquitoes	Number of Blood Fed Mosquitoes Alive For 3 Days After Capture	up to 8 months

Collaborators and Investigators

• Sponsor: Brian Foy
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); Radboud University Medical Center; Yale University; PATH; Institut de Recherche en Sciences de la Sante-Direction Regionale de l'Ouest
• Investigators: Principal Investigator: Brian D. Foy, PhD, Colorado State University; Principal Investigator: Sunil Parikh, MD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2019
• Primary Completion (Actual): November 8, 2020
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: May 24, 2019
• First Submitted That Met QC Criteria: May 28, 2019
• First Posted (Actual): May 30, 2019

Study Record Updates

• Last Update Posted (Estimated): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: ivermectin; mosquito; Plasmodium; Anopheles
• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Malaria; Anti-Infective Agents; Antiparasitic Agents; Ivermectin
• Other Study ID Numbers: 1691; U01AI138910 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data collected from this study, including de-identified individual participant data, will be made available upon publication to members of the scientific and medical community for non-commercial use only, upon email request to the corresponding author. The finalized study protocol, statistical analysis plan, and informed consent forms will be made available on ClinicalTrials.gov.
• IPD Sharing Time Frame: Within 6 mos of publication of the primary outcomes of the study.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No