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
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2009
CompletedFirst Posted
Study publicly available on registry
June 10, 2009
CompletedJune 10, 2009
June 1, 2009
June 9, 2009
June 9, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Adequate clinical and parasitolgical response (ACPR) until D 28
Secondary Outcomes (9)
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
- +4 more secondary outcomes
Study Arms (3)
MB3
EXPERIMENTAL3 days
MB5
EXPERIMENTAL5 days
MB7
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Complicated or severe malaria
- Any apparent significant disease
- Anaemia (haematocrit \< 21%)
- Increased creatinine blood levels
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nouna Health District
Nouna, Burkina Faso
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 9, 2009
First Posted
June 10, 2009
Last Updated
June 10, 2009
Record last verified: 2009-06