Malaria
Conditions
Brief summary
Design: Single-centre, controlled study in adults with uncomplicated falciparum malaria in the Nouna Health District, north-western Burkina Faso Phase: Phase II Objectives: The primary objective of this trial is to study the efficacy of different methylene blue regimens given to adults with uncomplicated falciparum malaria in an African area of high malaria transmission intensity. Population: Male adults with uncomplicated malaria from Nouna town. Sample size: N= 60 (n=20 for each group; three different dosing regimens of MB). Treatment: The participants in the three different MB regimens will receive orally twice daily 390 mg MB (total daily dose 780mg) over 7,5 or 3 days respectively. Treatment with the five (three) day regimen will only start after all patients of the seven (five) days regimen have been followed up until day 3. Endpoints: The primary endpoint is the adequate clinical and parasitological response (ACPR) rate on day 28. Secondary endpoints are the number of adverse events (AE) after drug intake until day 28, clinical and parasitological failure rates on day 14 and 28, changes in haemoglobin/haematocrit until day 28, and fever and parasite clearance time.
Interventions
DRUGMethylenblue
Sponsors
Heidelberg University
Eligibility
Sex/Gender
MALE
Age
17 Years to 55 Years
Inclusion criteria
* Male adults (\>17 years;\<55 years) * Uncomplicated malaria caused by P. falciparum * Asexual parasites ≥ 1000/µl and ≤ 200 000/µl * Axillary temperatures ≥ 37.5°C or history of fever during 48 hours * Living in nouna Health District * Informed consent
Exclusion criteria
* Complicated or severe malaria * Any apparent significant disease * Anaemia (haematocrit \< 21%) * Antimalarial treatment prior to inclusion (last three days) * Increased creatinine blood levels
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adequate clinical and parasitolgical response (ACPR) until D 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Late clinical failure (LCF) rate at D14 and D28 | — |
| Late parasitological failure (LPF) rate at D14 and D28 | — |
| Fever clearance time | — |
| Parasite clearance time | — |
| Early treatment failure (ETF) rate | — |
| Incidence of observed and self-reported non-serious adverse events over the 28 days observation period | — |
| Incidence of serious adverse events over the 28 days observation period | — |
| MB whole blood concentrations (trough concentrations) on day 3,5 or 7 compared to trough concentrations after the first dose | — |
| Change in haematocrit after 2,3,7,14 and 28 days compared to baseline | — |
Countries
Burkina Faso
Outcome results
None listed