Repeat Ivermectin Mass Drug Administrations for MALaria Control II

Malaria Clinical Trial

— RIMDAMAL 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03967054
• Other study ID #: 1691
• Secondary ID: U01AI138910
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 13, 2019
• Est. completion date: August 1, 2024

Study information

• Verified date: January 2024
• Source: Colorado State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4124
• Est. completion date: August 1, 2024
• Est. primary completion date: November 8, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Malaria

Intervention

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.
• Placebo oral tablet
placebo in the same size, color and shape at the ivermectin tablet

Locations

Country	Name	City	State
Burkina Faso	Institut de Recherche en Sciences de la Sante	Diebougou	Sud-Ouest

Sponsors (6)

Lead Sponsor	Collaborator
Brian Foy	Institut de Recherche en Sciences de la Sante-Direction Regionale de l'Ouest, National Institute of Allergy and Infectious Diseases (NIAID), PATH, Radboud University Medical Center, Yale University

Country where clinical trial is conducted

Burkina Faso, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Malaria Incidence	Incidence of malaria episodes in enrolled village children = 10 years of age	up to 8 months
Secondary	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
Secondary	Survival Rate of Blood Fed Mosquitoes	Number of Blood Fed Mosquitoes Alive For 3 Days After Capture	up to 8 months