Repeat Ivermectin Mass Drug Administrations for Control of Malaria: a Pilot Safety and Efficacy Study
RIMDAMAL
2 other identifiers
interventional
2,712
2 countries
2
Brief Summary
The purpose of this study is to determine whether repeated ivermectin mass drug administrations to Burkinabé villagers, performed in three week intervals over the rainy-season, is well-tolerated and safe, and also effective in reducing local malaria transmission and thus clinical malaria episodes in treated village children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2015
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 23, 2015
CompletedFirst Posted
Study publicly available on registry
July 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedResults Posted
Study results publicly available
January 4, 2019
CompletedJanuary 4, 2019
January 1, 2019
5 months
July 23, 2015
July 6, 2018
January 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Clinical Malaria Episodes
Cumulative incidence of malaria episodes in a cohort of village children ≤ 5 years of age (as assessed by active case surveillance in study villages - malaria episode defined as ≥38.0°C fever or history of fever in the last 24 hours + positive rapid diagnostic test for Plasmodium falciparum). Incidence is reported as malaria episodes per child over the course of the trial, a higher incidence is a worse outcome.
Approximately 18 weeks, from the start of the first MDA to 3 weeks following the last MDA in the Experimental arm
Secondary Outcomes (5)
Adverse Events
Approximately 18 weeks, from the start of the first MDA to 3 weeks following the last MDA in the Experimental arm
Entomological Indicator of Parasite Transmission
Approximately 20 weeks, from before the start of the first MDA to 4 weeks following the last MDA in the Experimental arm
Molecular Force of P. Falciparum Infection
Approximately 18 weeks, from the start of the first MDA to 3 weeks following the last MDA in the Experimental arm
Number of 6-10 Year Old Participants With Soil Transmitted Helminths (STH)
Approximately 20 weeks, from before the start of the first MDA to 4 weeks following the last MDA in the Experimental arm
Entomological Inoculation Rate
6 sampling periods over 18 weeks, starting in week 2 following the first MDA, and sampling every 3 weeks thereafter until week 17 of the treatment phase.
Study Arms (2)
Single MDA
ACTIVE COMPARATORSingle mass drug administration of ivermectin (150 µg/kg) + albendazole (400 mg) performed after the start of the rainy season as part of public health efforts to eliminate lymphatic filariasis.
Repeated MDA
EXPERIMENTALSame at Active Comparator, but then followed by five more mass drug administrations of ivermectin only (150 µg/kg) every three weeks thereafter.
Interventions
Eligibility Criteria
You may qualify if:
- Residence in the study site
- Able to understand the information and willing to give consent and assent (parent or guardian consent if study participant age is \< 18 years)
You may not qualify if:
- Residence outside of in the study site
- Height ≤ 90 cm
- Permanent disability, serious medical illness that prevents or impedes study participation and/or comprehension
- Pregnancy
- Breast feeding if infant is within 1 week of birth
- Known allergy to the study drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Colorado State Universitylead
- Institut de Recherche en Sciences de la Sante, Burkina Fasocollaborator
- Centre Murazcollaborator
- Ministère de la Santé du Burkina Fasocollaborator
Study Sites (2)
Colorado State University
Fort Collins, Colorado, 80523, United States
Institut de Recherche en Sciences de la Santé
Bobo-Dioulasso, Houet, 10400-000, Burkina Faso
Related Publications (1)
Foy BD, Alout H, Seaman JA, Rao S, Magalhaes T, Wade M, Parikh S, Soma DD, Sagna AB, Fournet F, Slater HC, Bougma R, Drabo F, Diabate A, Coulidiaty AGV, Rouamba N, Dabire RK. Efficacy and risk of harms of repeat ivermectin mass drug administrations for control of malaria (RIMDAMAL): a cluster-randomised trial. Lancet. 2019 Apr 13;393(10180):1517-1526. doi: 10.1016/S0140-6736(18)32321-3. Epub 2019 Mar 14.
PMID: 30878222DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
We could not provide placebo MDA for the control villages, and the trial was not blinded to the study population or the study team. Adverse event analysis bias may have from the knowledge of the village populace as to what arm they were part of.
Results Point of Contact
- Title
- Dr. Brian D. Foy, Professor
- Organization
- Colorado State University
Study Officials
- PRINCIPAL INVESTIGATOR
Brian D. Foy, PhD
Colorado State University
- PRINCIPAL INVESTIGATOR
Roch K Dabire, PhD
Institute de Recherche en Sciences de la Santé
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2015
First Posted
July 28, 2015
Study Start
June 1, 2015
Primary Completion
November 1, 2015
Study Completion
December 1, 2015
Last Updated
January 4, 2019
Results First Posted
January 4, 2019
Record last verified: 2019-01