Trial intelligence / Profile preview

Effectiveness of Seasonal Malaria Chemoprevention in Koulikoro, Mali

NCT04149106Phase 3

Key facts

Status
Unknown
Start
Jul 2019
Primary completion
Dec 2022
Countries
1
Sponsor
University Clinical Research Center
Modality
Bivalent/Multivalent Binders, Nucleic Acid-Directed Small Molecules, Orthosteric Ligands
Conditions
Malaria
01

Overview

Phase 3, randomised, open-label trial of dihydroartemisinin + piperaquine in Malaria (3 arms), sponsored by University Clinical Research Center. Primary endpoint: Malaria incidence among cohort in 2 years period. Status: unknown.

02

Design

3 arms
Study design
RandomizedOpen-label
  • Standard

    SMC with SP+AQ for children < 5 years.

  • Extension

    SMC with SP+AQ for children < 10 years.

  • Alternative

    SMC with DHA-PQ for children < 10 years.

03

Who it enrols

Children aged 3 months to 119 months residing in the village, without chronic diseases or allergies to study drugs.

04

Endpoints

Primary

  • Malaria incidence among cohort in 2 years period

Secondary

  • Malaria infection prevalence at the start and the end of malaria transmission season

  • Drug resistance marker prevalence in two 2 years period

  • SMC coverage and treatment compliance during malaria transmission season

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