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

Phase 2

Completed

• Conditions: Uncomplicated Falciparum Malaria
• Interventions: Drug: artesunate (AS) - amodiaquine (AQ) - methylene blue (MB)

• Registration Number: NCT01407887
• Lead Sponsor: Heidelberg University

Brief 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-06
• Study Start: 2011-08
• Primary Completion: 2011-08
• Study First Submitted: 2011-08-01
• Study First Submitted QC: 2011-08-01
• Study First Posted: 2011-08-02
• Study Completion: 2011-12
• Last Update Submitted: 2012-12-04
• Last Update Posted: 2012-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• 6-59 months old children (male and female)
• Weight ≥ 6kg
• Uncomplicated malaria caused by P. falciparum
• Asexual parasites ≥ 2 000/µl and ≤ 200 000/µl
• Axillary temperature ≥ 37.5°C or a history of fever during last 24 hours
• Burkinabe nationality
• Permanent residence in the study area with no intention of leaving during the surveillance period
• Informed consent

Exclusion Criteria

• Severe malaria (WHO 2000)
• Vomiting (3 or more within 24 hours before the visit)
• Any apparent significant disease, including severe malnutrition
• A history of a previous, significant adverse reaction to either of the study drugs
• Anaemia (haemoglobin < 7 g/dl)
• Treated in the same trial before
• All modern antimalarial treatment prior to inclusion (last seven days)
• Simultaneous participation in another investigational study
• Treatment with other investigational drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
artesunate, amodiaquine methylene blue	artesunate (AS) - amodiaquine (AQ) - methylene blue (MB)	two arms, open randomized controlled study in children with uncomplicated falciparum malaria in Burkina Faso. Intervention: artesunate (AS) - amodiaquine (AQ) - methylene blue (MB) control: artesunate (AS) - amodiaquine (AQ)

Primary Outcome Measures

Name	Time	Method
P. falciparum gametocyte prevalence	day 14 of follow-up	P. falciparum gametocyte prevalence on day 14 of follow-up (PCR determination)

Secondary Outcome Measures

Name	Time	Method
P. falciparum gametocyte prevalence and density	day 1, 2, 3, 7, and 28 of follow-up	P. falciparum gametocyte prevalence and density on day 1, 2, 3, 7, and 28 of follow-up (PCR determination) P. falciparum gametocyte prevalence and density on day 1, 2, 3, 7, and 28 of follow-up (microscopic determination)

Trial Locations

Locations (1)

Nouna Health District; 🇧🇫 Nouna, Mouhoun, Burkina Faso