Phase 3
N=2,712
Repeat Ivermectin Mass Drug Administrations for Control of Malaria: a Pilot Safety and Efficacy Study
Malaria · Lymphatic Filariasis
Bottom Line
View on ClinicalTrials.gov: NCT02509481 ↗Enrolled (actual)
2,712
Serious AEs
1.1%
Results posted
Jan 2019
Primary outcome: Primary: Incidence of Clinical Malaria Episodes — 2.49; 2.00 episodes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ivermectin (Drug); Albendazole (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Colorado State University
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Clinical Malaria Episodes |
2.49; 2.00 | — |
| SECONDARY Adverse Events |
24; 45 | — |
| SECONDARY Entomological Indicator of Parasite Transmission |
-0.057; -0.124 | — |
| SECONDARY Molecular Force of P. Falciparum Infection |
4; 3 | — |
| SECONDARY Number of 6-10 Year Old Participants With Soil Transmitted Helminths (STH) |
3; 0 | — |
| SECONDARY Entomological Inoculation Rate |
0.2069; 0.1972 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02509481). 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.