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Efficacy of Artesunate-amodiaquine and Artemether-lumefantrine for Uncomplicated Malaria in South Kivu, DR Congo

NCT02741024 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2016-04-18

No results posted yet for this study

Summary

This will be an open-randomised non-inferiority study to test the hypothesis that the risk of recurrent parasitaemia after 42 days is not worse in the group receiving the Artesunate-Amodiaquine (ASAQ) regimen than in the group receiving the Artemether-Lumefantrine (Coartem®) regimen. Children with uncomplicated malaria meeting the inclusion criteria will be enrolled (after their parent/caretaker has given informed consent), treated on site with the drugs under evaluation and followed-up for a period of 42 days. Drugs will be given under direct supervision, either at the clinic or at home. Follow-up shall consist of a fixed schedule of clinical and laboratory examinations. Based on clinical and laboratory findings, children will be classified as therapeutic failures (early or late) or adequate responders.

The proportion of cases experiencing an in vivo therapeutic failure during the follow-up period will provide an estimate of the efficacy of the drug regimens. A Polymerase Chain Reaction (PCR) analysis will be carried out to differentiate true recrudescence due to treatment failure from episodes of re-infection. This proposal is compliant with the latest WHO recommendations for anti-malarial efficacy monitoring in high, medium or low transmission zones11.

Conditions

Interventions

DRUG

Amodiaquine-Artesunate (ASAQ)

Treatment on site with Amodiaquine-Artesunate according to the manufacturer's dose and instruction and follow-up for a period of 42 days. Drugs will be given under direct supervision, either at the clinic or at home

DRUG

Artemether-Lumefantrine (AL)

Treatment on site with Artemether-lumefantrine combination according to the manufacturer's dose and instruction and follow-up for a period of 42 days.

Sponsors & Collaborators

  • Medecins Sans Frontieres, Netherlands

    lead OTHER

Principal Investigators

  • Marit de Wit, MD, MIH · Medecins sans Frontieres, Operational Centre Amsterdam

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
2013-10-31
Primary Completion
2014-12-31
Completion
2014-12-31

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Entities

Diseases

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 NCT02741024 on ClinicalTrials.gov