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Efficacy and Safety of Artesunate-amodiaquine-methylene for Malaria Treatment in Children

NCT01407887 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2012-12-05

No results posted yet for this study

Summary

Title: Efficacy and safety of artesunate-amodiaquine combined with methylene blue for falciparum malaria treatment in African children: randomised controlled trial.

Design: Mono-centre, two arms, open randomized controlled study in children with uncomplicated falciparum malaria in Burkina Faso.

Phase: Phase II.

Objectives: The primary objective of this trial is to study the efficacy and safety of the triple therapy artesunate (AS) - amodiaquine (AQ) - methylene blue (MB) given over three days in young children with uncomplicated falciparum malaria in Burkina Faso compared to the local standard three days artemisinin-based combination therapy (ACT) AS-AQ regimen.

Population: Children aged 6-59 months with uncomplicated falciparum malaria from Nouna Hospital in north-western Burkina Faso.

Sample size: 180 patients (90 per study arm).

Conditions

  • Uncomplicated Falciparum Malaria

Interventions

DRUG

artesunate (AS) - amodiaquine (AQ) - methylene blue (MB)

The group AS-AQ-MB will receive once daily a fixed dose AS-AQ formulation combined with once daily MB over a three days period.

Sponsors & Collaborators

  • Heidelberg University

    lead OTHER

Principal Investigators

  • Olaf Müller, Prof Dr · Institut of Public health, University of heidelberg

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
2011-08-31
Primary Completion
2011-08-31
Completion
2011-12-31

Countries

  • Burkina Faso

Study Locations

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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 NCT01407887 on ClinicalTrials.gov