Malaria Clinical Trial
Official title:
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
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.
n/a
N/A
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