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Phase 3 Completed N=2,712 Randomized Single-blind Treatment

Repeat Ivermectin Mass Drug Administrations for Control of Malaria: a Pilot Safety and Efficacy Study

Source: ClinicalTrials.gov NCT02509481 ↗
Enrolled (actual)
2,712
Serious AEs
1.1%
Results posted
Jan 2019
Primary outcomePrimary: Incidence of Clinical Malaria Episodes — 2.49; 2.00 episodes
◆ Published Evidence
Highly cited
143citations · ~20 / year
Efficacy and risk of harms of repeat ivermectin mass drug administrations for control of malaria (RIMDAMAL): a cluster-randomised trial.
Lancet (London, England) · 2019 · Open access · Likely link

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.

Linked Publications

  • Efficacy and risk of harms of repeat ivermectin mass drug administrations for control of malaria (RIMDAMAL): a cluster-randomised trial.
    Lancet (London, England) · 2019 · 143 citations · Open access · Likely link

Outcome Measures

OutcomeResultp-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

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02509481) and the linked publication. 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. Informational only — not medical advice.

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