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Efficacy of Artesunate + Amodiaquine Versus Artemether-lumefantrine for Falciparum Malaria in Zanzibar, 2005

NCT03768908 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 359

Last updated 2018-12-07

No results posted yet for this study

Summary

The primary objective of the study was to determine the PCR-APCR up to day 42 in children \<60 months of age, weighing ≥5kg with uncomplicated malaria, treated with either artesunate+ amodiaquine (ASAQ) or artemether-lumefantrine (AL; Coartem®).

Secondary objectives included: clinical and laboratory assessment of drug tolerability and safety, evaluation of possible correlation between drug bioavailability and clinical outcome, comparison of efficacy data with the pre-implementation "ACO I" study, parasite and fever clearance, gametocyte carriage, and possible selection of mutations related to quinoline resistance.

Conditions

  • Plasmodium Falciparum Malaria

Interventions

DRUG

Artemether-lumefantrine

Three day treatment with Artemether-lumefantrine, 2 doses a day under direct observation

DRUG

Artesunate + Amodiaquine

Three day treatment with Artesunate + Amodiaquine, co-administered, a dose a day under direct observation

Sponsors & Collaborators

  • Zanzibar Malaria Control Programme

    collaborator OTHER_GOV

  • Professor Anders Björkman

    lead OTHER

Principal Investigators

  • Johan Stromberg · Karolinska Institutet

  • Mwinyi I Msellem · Zanzibar Malaria Control Programme

  • Andreas Martensson · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE

Eligibility

Max Age
60 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-05
Primary Completion
2005-07-11
Completion
2005-07-11

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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 NCT03768908 on ClinicalTrials.gov