Overview

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

Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Heidelberg University
Treatments:
Amodiaquine
Artemisinins
Artesunate
Methylene Blue
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