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Safety and Efficacy of Recommended Antimalarial in the Democratic Republic of the Congo

NCT04618523 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1117

Last updated 2022-02-09

No results posted yet for this study

Summary

Despite all efforts, malaria remains a public health concern, in particular in the Democratic Republic of the Congo (DRC). The National Malaria Control program recommends artemisinin-based combination treatments (ACTs), in particular artesunate-amodiaquine or artemether-lumefrantrine for the treatment of uncomplicated malaria. Previous studies indicated that ACTs are still effective, with efficacy above the required threshold of 90%. It is required to assess regularly the efficacy of antimalarial drugs. I In case of increasing failure rates, alternative options can be decided ontime.

The purpose of this trial is to assess efficacy and safety of artesunate-amodiaquine (ASAQ Winthrop®) and artemether-lumefantrine (Coartem Dispersible®) at day 28 in the treatment of uncomplicated Plasmodium falciparum malaria in six surveillance sites around DRC.

Conditions

Interventions

DRUG

Artesunate-amodiaquine

Artemisinin-based combination treatment

DRUG

Artemether-lumefantrine

Artemisinin-based combination treatment

Sponsors & Collaborators

  • University of Kinshasa

    collaborator OTHER

  • World Health Organization

    collaborator OTHER

  • Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo

    collaborator OTHER

  • Ministry of Public Health, Democratic Republic of the Congo

    lead OTHER_GOV

Principal Investigators

  • Gauthier Mesia Kahunu, PhD · University of Kinshasa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-26
Primary Completion
2022-02-08
Completion
2022-02-08

Countries

  • Democratic Republic of the Congo

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04618523 on ClinicalTrials.gov