Malaria
Conditions
Brief summary
The purpose of the study is to investigate the safety and efficacy profile of a new paediatric MB formulation combined with AQ or AS and compared to AS-AQ in young African children with uncomplicated falciparum malaria.
Interventions
DRUGMethylenblue-Amodiaquine (MB-AQ)
For 3 days twice daily 10 mg/kg MB accompanied by once daily 10 mg/kg AQ
DRUGMethylenblue-Artesunate (MB-AS)
3 days once daily 4 mg/kg AS accompanied by twice daily 10 mg/kg MB given over 7 days
For 3 days once daily 10 mg/kg AQ accompanied by 4mg/kg AS.
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
Inclusion criteria
* 0.5-5 year (6-59 months) old children * uncomplicated malaria caused by P. falciparum * asexual parasites ≥ 2000/µ and ≤ 200000/µ * axillary temperature ≥ 37.5 Celsius or a history of fever during last 24 hours * Burkinabe nationality * informed consent
Exclusion criteria
* complicated or severe malaria * any apparent significant disease * anaemia (haematocrit \< 21%) * treated in the same trial before * modern antimalarial treatment prior to inclusion (last three days), except children having been treated with chloroquine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of observed and self-reported non-serious adverse events over the 28 days observation period | 28 days |
Secondary
| Measure | Time frame |
|---|---|
| Early treatment failure (ETF) rate | 28 days |
| Late clinical failure (LCF) rate at D14 and D28 | 28 days |
| Late parasitological failure (LPF) rate at D14 and D28 | 28 days |
| Incidence of serious adverse events (SAE) and the adequate clinical and parasitological response rate (ACPR) | 28 days |
| Parasite clearance time | 28 days |
| Change in haematocrit after 2,14 and 28 days compared to baseline | 28 days |
| MB whole blood concentrations on D3,5 or 7 compared to concentrations after the first dose | 28 days |
| Fever clearance time | 28 days |
Countries
Burkina Faso
Outcome results
None listed