Last Updated: 27/10/2016
Repeat Ivermectin Mass Drug Administrations for Control of Malaria (RIMDAMAL)
Objectives
*Alternative title: Dry-to-rainy Season Integrated Control of NTDs and Malaria
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.
Repeated Ivermectin Mass Drug Administration (MDA) starting at the beginning of the rainy season will be well tolerated and safe and will reduce clinical malaria episodes in children by significantly reducing malaria transmission among treated villages.
Single-blind (outcomes assessor); parallel assignment with 2 arms; cluster-randomized control trial to determine the effect of repeated IVM MDA on malaria transmission and clinical malaria episodes.
The unit of randomization will be the village (cluster). 8 villages total will be enrolled in two arms. The active comparator arm (4 villages) will receive a single standard MDA (IVM; 150-200 µg/kg + albendazole; 400 mg) soon after the start of the rainy season, while the experimental arm (4 villages) will receive the standard MDA on the same date, plus 5 more IVM MDA at 3 week intervals thereafter.
Dose (ivermectin): 150 µg/kg
Outcome measures:
- Primary outcome: Incidence of Clinical Malaria Episodes (timeframe approximately 18 weeks, from the start of the first MDA to 3 weeks following the last MDA in the experimental arm)
- Secondary outcomes: adverse events, entomological indicator of parasite transmission, molecular force of P. falciparum infection, number of 6-10 year old participants with soil-transmitted helminths and entomological inoculation rate.
ClinicalTrials.gov Identifier: NCT02509481
| Study Type : | Interventional (Clinical Trial) |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
Jan 2014 — Apr 2016
$100,000
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