Clinical trial NCT01407887: Efficacy and Safety of Artesunate-amodiaquine-methylene for Malaria Treatment in Children
Official title: Efficacy and Safety of Artesunate-amodiaquine Combined With Methylene Blue for Falciparum Malaria Treatment in African Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Uncomplicated Falciparum Malaria
Keywords: children
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2011-08-02
Enrollment: 180
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: P. falciparum gametocyte prevalence
timeFrame: day 14 of follow-up
Secondary outcomes:
measure: P. falciparum gametocyte prevalence and density
timeFrame: day 1, 2, 3, 7, and 28 of follow-up
Other outcomes:
Locations:
city: Nouna
country: Burkina Faso
facility: Nouna Health District
state: Mouhoun
Study officials:
affiliation: Institut of Public health, University of heidelberg
name: Olaf Müller, Prof Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coulibaly B, Pritsch M, Bountogo M, Meissner PE, Nebie E, Klose C, Kieser M, Berens-Riha N, Wieser A, Sirima SB, Breitkreutz J, Schirmer RH, Sie A, Mockenhaupt FP, Drakeley C, Bousema T, Muller O. Efficacy and safety of triple combination therapy with artesunate-amodiaquine-methylene blue for falciparum malaria in children: a randomized controlled trial in Burkina Faso. J Infect Dis. 2015 Mar 1;211(5):689-97. doi: 10.1093/infdis/jiu540. Epub 2014 Sep 28.