Repeat Ivermectin Mass Drug Administrations for Control of Malaria: a Pilot Safety and Efficacy Study (RIMDAMAL)
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|ClinicalTrials.gov Identifier: NCT02509481|
Recruitment Status : Completed
First Posted : July 28, 2015
Results First Posted : January 4, 2019
Last Update Posted : January 4, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Malaria Lymphatic Filariasis||Drug: Ivermectin Drug: Albendazole||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2712 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Repeat Ivermectin Mass Drug Administrations for Control of Malaria: a Pilot Safety and Efficacy Study|
|Study Start Date :||June 2015|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||December 2015|
Active Comparator: Single MDA
Single 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.
Other Name: Mectizan
Experimental: Repeated MDA
Same at Active Comparator, but then followed by five more mass drug administrations of ivermectin only (150 µg/kg) every three weeks thereafter.
Other Name: Mectizan
- Incidence of Clinical Malaria Episodes [ Time Frame: Approximately 18 weeks, from the start of the first MDA to 3 weeks following the last MDA in the Experimental arm ]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.
- Adverse Events [ Time Frame: Approximately 18 weeks, from the start of the first MDA to 3 weeks following the last MDA in the Experimental arm ]The number of adverse events. Adverse events data were collected via passive case detection from total population.
- Entomological Indicator of Parasite Transmission [ Time Frame: Approximately 20 weeks, from before the start of the first MDA to 4 weeks following the last MDA in the Experimental arm ]Change in human IgG reactivity (optical density; ∆OD) to an Anopheles salivary gland antigen (peptide gSG6-P1) over the trial period. A score of 0 indicates no change in seroreactivity from from immediately before to immediately after the trial, suggesting consistent mosquito biting throughout the trial. A positive score indicates increasing seroreactivity and thus increasing mosquito biting on participants from immediately before to immediately after the trial. A negative score indicates decreasing seroreactivity and thus decreasing mosquito biting on participants from immediately before to immediately after the trial.
- Molecular Force of P. Falciparum Infection [ Time Frame: Approximately 18 weeks, from the start of the first MDA to 3 weeks following the last MDA in the Experimental arm ]Examination of new P. falciparum clones acquired from the beginning to the end of the intervention (molecular force of infection; mFOI) per child. Molecular genotyping used capillary blood taken at the time of diagnosis of each positive malaria episode and consisted of nPCR of the msp2 gene. We calculated the multiplicity of infection (MOI) per malaria episode, and then calculated the molecular force of infection (mFOI) associated with malaria episodes per child (over course of the trial)
- Number of 6-10 Year Old Participants With Soil Transmitted Helminths (STH) [ Time Frame: Approximately 20 weeks, from before the start of the first MDA to 4 weeks following the last MDA in the Experimental arm ]Prevalence of soil transmitted helminth infections in children between 6-10 years old from the beginning to the end of the intervention
- Entomological Inoculation Rate [ Time Frame: 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. ]The entomological inoculation rate (EIR per week per person) is the measure of the human biting rate per person per week, multiplied by the sporozoite rate (in biting mosquitoes) per week, an estimated from sampling mosquitoes from 8 households located in the center of each study village. The EIR was calculated for each of the 6 sampling weeks of the treatment phase.
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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)
- Residence outside of in the study site
- Height ≤ 90 cm
- Permanent disability, serious medical illness that prevents or impedes study participation and/or comprehension
- Breast feeding if infant is within 1 week of birth
- Known allergy to the study drugs
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02509481
|United States, Colorado|
|Colorado State University|
|Fort Collins, Colorado, United States, 80523|
|Institut de Recherche en Sciences de la Santé|
|Bobo Dioulasso, Houet, Burkina Faso, 10400-000|
|Principal Investigator:||Brian D. Foy, PhD||Colorado State University|
|Principal Investigator:||Roch K Dabire, PhD||Institute de Recherche en Sciences de la Santé|
Documents provided by Colorado State University:
|Responsible Party:||Colorado State University|
|Other Study ID Numbers:||
OPP1116536 ( Other Grant/Funding Number: The Bill and Melinda Gates Foundation )
|First Posted:||July 28, 2015 Key Record Dates|
|Results First Posted:||January 4, 2019|
|Last Update Posted:||January 4, 2019|
|Last Verified:||January 2019|
mass drug administration
Vector Borne Diseases
Molecular Mechanisms of Pharmacological Action