Efficacy of Methylene Blue for Malaria Treatment in Adults of Burkina Faso: Proof of Principle Study in Semi-Immune Adults of Burkina Faso in the Frame of the A8 Project of the SFB 544

Heidelberg University

Overview

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.

Study Type

INTERVENTIONAL

Conditions

Malaria

Interventions

MethylenblueDRUG

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Adequate clinical and parasitolgical response (ACPR) until D 28

Secondary Outcomes

Early treatment failure (ETF) rate

Late clinical failure (LCF) rate at D14 and D28

Late parasitological failure (LPF) rate at D14 and D28

Fever clearance time

Parasite clearance time

Change in haematocrit after 2,3,7,14 and 28 days compared to baseline

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