Phase 3
N=4,124
Repeat Ivermectin Mass Drug Administrations for MALaria Control II
Malaria
Bottom Line
View on ClinicalTrials.gov: NCT03967054 ↗Enrolled (actual)
4,124
Serious AEs
0.3%
Results posted
Jan 2024
Primary outcome: Primary: Malaria Incidence — 0.0176; 0.0183 Malaria cases per person-week
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ivermectin (Drug); Placebo oral tablet (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Brian Foy
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Malaria Incidence |
0.0176; 0.0183 | — |
| SECONDARY Adverse Events |
438; 402 | — |
| SECONDARY Survival Rate of Blood Fed Mosquitoes |
399; 896 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03967054). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.