Repeat Ivermectin Mass Drug Administrations for MALaria Control II

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

4124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-13

Study Completion Date

2024-08-01

Brief Summary

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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.

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Detailed Description

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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

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Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Ivermectin

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Placebo oral tablet

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

Intervention Type DRUG

Other Intervention Names

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Iver P

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes