Clinical trial NCT00917202: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malaria
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2009-06-10
Sex: MALE
Minimum age (years): 17
Maximum age (years): 55
Standard ages: CHILD
ADULT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Adequate clinical and parasitolgical response (ACPR) until D 28
Secondary outcomes:
measure: Early treatment failure (ETF) rate
measure: Late clinical failure (LCF) rate at D14 and D28
measure: Late parasitological failure (LPF) rate at D14 and D28
measure: Fever clearance time
measure: Parasite clearance time
measure: Change in haematocrit after 2,3,7,14 and 28 days compared to baseline
measure: Incidence of observed and self-reported non-serious adverse events over the 28 days observation period
measure: Incidence of serious adverse events over the 28 days observation period
measure: MB whole blood concentrations (trough concentrations) on day 3,5 or 7 compared to trough concentrations after the first dose
Other outcomes:
Locations:
city: Nouna
country: Burkina Faso
facility: Nouna Health District
Study officials:
References: