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Tolerability and Efficacy of Artemether-Lumefantrine Versus Artesunate + Amodiaquine in Zanzibar

NCT03764527 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 408

Last updated 2018-12-06

No results posted yet for this study

Summary

The primary objective of the study was to determine PCR corrected cure-rates up to day 42 in children with uncomplicated malaria, treated with either Artesunate + Amodiaquine or Coartem®.

Secondary objectives were to determine safety and possible selection of mutations related to the resistance of the tested drugs.

Conditions

  • Plasmodium Falciparum Malaria

Interventions

DRUG

Artemether-lumefantrine

Two doses a day for 3 days, under supervision

DRUG

Coadministered Artesunate plus Amodiaquine

One dose a day for 3 days, under supervision

Sponsors & Collaborators

  • Zanzibar Malaria Control Programme

    collaborator OTHER_GOV

  • World Health Organization

    collaborator OTHER

  • Professor Anders Björkman

    lead OTHER

Principal Investigators

  • Abdullah Ali · Zanzibar Malaria Control Programme

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
2002-11-01
Primary Completion
2003-02-17
Completion
2003-02-17

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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 NCT03764527 on ClinicalTrials.gov