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Net Transition Initiative: Efficacy of Two Next-generation Nets for Control of Malaria in Cote d'Ivoire

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Primary completion date: Oct 2024 to Mar 2027v3 Show 6 more changesShow less
    • Study completion date: Dec 2024 to Jul 2027
    • Interventions: Alpha-cypermethrin and Clorfenapyr LLIN (Other), Alpha-cypermethrin and PBO LLIN (Other), Alpha-cypermethrin only LLIN (Other) to Alpha-cypermethrin and Clorfenapyr LLIN (Other), Alpha-cypermethrin and PBO LLIN (Other), Alpha-cypermethrin only LLIN (Other)…
    • Secondary endpoints: 6 to 10
    • Study description expanded, about 120 words
    • Collaborators: 3 to 4
    • Study arms: 3 to 6
  2. Minor Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Study sites: 0 to 1
    • Primary completion date: Jul 2024 to Oct 2024
    • Start date changed from estimate of Jul 2023 to Oct 2, 2023
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The investigator plan to conduct a three-arm cluster-randomized control trial which compares two next generation of long-lasting Insecticidal Nets (LLINs); Veeralin®LLIN (PBO-py LLIN), Interceptor G2 (chlorfenapyr-py LLIN) to a standard py-LLIN in the department of Tiebissou Southern Bouake city, central Côte d'Ivoire. The primary objective of the project is to evaluate the efficacy of chlorfenapyr-pyrethroid and piperonyl-butoxide (PBO) synergist-pyrethroid LLINs on malaria case incidence in children aged 6 months to 10 years compared to standard pyrethroid-only LLINs. The secondary objectives are to evaluate the efficacy of the two intervention LLINs compared to the standard LLIN on a) malaria infection prevalence in the general population (both children and adults), b) vector density and c) entomological inoculation rate (EIR) (as a proxy for malaria transmission). In addition, changes in phenotypic resistance intensity and selection for molecular resistance mechanisms at baseline and 12 months post-LLIN distribution, in sentinel villages in each treatment arm will be investigate. It is vital to demonstrate that these next generation LLINs which are becoming the standard of care in Sub Saharan AFRICA, are superior to standard py-LLIN in the most extreme resistance areas as this is likely where alternative interventions will be most needed to keep malaria control on track. The trial will generate the first epidemiological evidence on the efficacy of PBO nets compared to py-LLIN in West Africa. UPDATE: Following 1 year of follow-up, the trial was extended to assess the impact of the nets over a 3 year follow-up. In addition, we introduced school-based net top ups in half of the clusters- to evaluate the impact of top-up strategies on net ownership, access and usage and malaria outcomes.
Trial Details
NCT Number NCT05796193
Lead Sponsor London School of Hygiene and Tropical Medicine
Collaborators: Institut Pierre Richet, University of Ottawa, University of Nevada, Las Vegas, Swiss Tropical & Public Health Institute
Conditions
(from sponsor)
Malaria
Related terms Malaria
Enrollment 1,650 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov