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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Malaria

Intervention / Treatment
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* Drug: Methylenblue


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MB3<br>3 days | Drug: Methylenblue<br> <br> |
| Experimental: MB5<br>5 days | Drug: Methylenblue<br> <br> |
| Experimental: MB7<br> | Drug: Methylenblue<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequate clinical and parasitolgical response (ACPR) until D 28 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  |