Uncomplicated Falciparum Malaria
Conditions
Keywords
children
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).
Interventions
DRUGartesunate (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
Heidelberg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 59 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| P. falciparum gametocyte prevalence | day 14 of follow-up | P. falciparum gametocyte prevalence on day 14 of follow-up (PCR determination) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Burkina Faso
Outcome results
None listed