Clinical trial NCT03967054: Repeat Ivermectin Mass Drug Administrations for MALaria Control II
Official title: Repeat Ivermectin Mass Drug Administrations for MALaria Control II (RIMDAMAL II): a Double-blind, Cluster-randomized Control Trial for Integrated Control of Malaria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malaria
Keywords: mosquito
ivermectin
Anopheles
Plasmodium
Lead sponsor: Colorado State University
Sponsor class: OTHER
Collaborators: name: Yale University
name: Institut de Recherche en Sciences de la Sante-Direction Regionale de l'Ouest
name: Radboud University Medical Center
name: PATH
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2019-05-30
Enrollment: 4124
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel-assignment trial with two arms randomized in a 1:1 ratio.
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Malaria Incidence
timeFrame: up to 8 months
Secondary outcomes:
measure: Adverse Events
timeFrame: up to 8 months
measure: Survival Rate of Blood Fed Mosquitoes
timeFrame: up to 8 months
Other outcomes:
Locations:
city: Diebougou
country: Burkina Faso
facility: Institut de Recherche en Sciences de la Sante
state: Sud-Ouest
Study officials:
affiliation: Colorado State University
name: Brian D. Foy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Sunil Parikh, MD
role: PRINCIPAL_INVESTIGATOR
References: