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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:

Primary Objective: To determine the efficacy of repeated ivermectin mass drug administrations (IVM MDA) (150 µg/kg), given to the population of eligible patients in enrolled villages, for reducing the cumulative incidence of uncomplicated malaria episodes in enrolled village children (≤ 5 years of age) over the course of the treatment.

Hypothesis: Repeated IVM 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.

Overview Study Design: 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. The primary endpoint will be the cumulative incidence of clinical malaria episodes in children ≤5 year of age within each village.

Sites: This study will be conducted in villages along the main east-west and north-south road corridors in the Sud-Ouest administrative region of Burkina Faso.

Study Population: Indigenous Burkinabé from various ethnic groups (Dagara, Bobo, Lobi, Mossi, etc.). The entire eligible population of each enrolled village will receive the MDAs, following the standard inclusion/exclusion criteria of MDA f
Sponsor: Colorado State University

Current Primary Outcome: 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 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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Force of Plasmodium falciparum infection [ Time Frame: Approximately 20 weeks, from before the start of the first MDA to 4 weeks following the last MDA in the Experimental arm ]
    Examination of new P. falciparum infections acquired from the beginning to the end of the intervention (molecular force of infection)
  • Soil transmitted helminths [ Time Frame: Approximately 20 weeks, from before the start of the first MDA to 4 weeks following the last MDA in the Experimental arm ]
    Examination of prevalence and intensity of soil transmitted helminth infections in children between 6-10 years old from the beginning to the end of the intervention
  • Entomological indicators of parasite transmission [ Time Frame: Approximately 20 weeks, from before the start of the first MDA to 3 weeks following the last MDA in the Experimental arm ]
    Indoor-resting blood fed and host-seeking Anopheles mosquitoes from houses in the center of each village will be identified and counted, and subset samples will be tested for parity, Plasmodium sporozoites, and infections with Wuchereria bancrofti.
  • 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, frequency and type (classified by seriousness, causality and expectedness) of adverse events. Adverse events data are collected via passive case detection.


Original Secondary Outcome: Same as current

Information By: Colorado State University

Dates:
Date Received: July 23, 2015
Date Started: June 2015
Date Completion:
Last Updated: August 22, 2016
Last Verified: July 2015