RIMDAMAL II: Repeat Ivermectin Mass Drug Administrations for MALaria Control II
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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 Design
Arms and Interventions
| 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:
|
| 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
|
Outcome Measures
Primary Outcome Measures
- Malaria incidence [up to 8 months]
Incidence of uncomplicated malaria episodes in enrolled village children ≤ 10 years of age
Secondary Outcome Measures
- Adverse Events [up to 25 months]
Number of participants with adverse events in the study population over the course of the intervention period
- Blood fed mosquito mortality [up to 8 months]
Rate of blood fed mosquito mortality following capture
- Entomological inoculation rate [Approximately 8 months over 2 consecutive rainy seasons (2019-2020)]
Rate of infectious mosquito bites per cross-section participant over time
- Human antibody responses to an Anopheles salivary gland peptide [up to 8 months]
IgG antibody reactivity from cross-section participants to an Anopheles salivary gland peptide over each rainy season
- Plasmodium prevalence [up to 8 months]
Proportion of cross-section participants with Plasmodium blood infections over time
- Plasmodium parasitemia [up to 8 months]
Density of Plasmodium parasites in the blood of cross-section participants over time
- Plasmodium multiplicity of infection [up to 8 months]
number of Plasmodium clones per infected blood sample from infected cross-section participants over time
- Plasmodium molecular force of infection [up to 8 months]
number of new Plasmodium clones per cross-section participant over time
Eligibility Criteria
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]):
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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)
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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
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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)
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Breast feeding if infant is within 1 week of birth
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Known allergy to ivermectin
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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.
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Enrolled in any other active clinical trials
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institut de Recherche en Sciences de la Sante | Diebougou | Sud-Ouest | Burkina Faso |
Sponsors and Collaborators
- Brian Foy
- Yale University
- Institut de Recherche en Sciences de la Sante
- Radboud University Medical Center
- PATH
Investigators
- Principal Investigator: Brian D. Foy, PhD, Colorado State University
- Principal Investigator: Sunil Parikh, MD, Yale University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 18-1803H