Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by:
Heidelberg University Identifier:
First received: June 9, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted

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.

Condition Intervention Phase
Drug: Methylenblue
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Adequate clinical and parasitolgical response (ACPR) until D 28

Secondary Outcome Measures:
  • 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

Arms Assigned Interventions
Experimental: MB3
3 days
Drug: Methylenblue
Experimental: MB5
5 days
Drug: Methylenblue
Experimental: MB7 Drug: Methylenblue


Ages Eligible for Study:   17 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   Male

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00917202

Burkina Faso
Nouna Health District
Nouna, Burkina Faso
Sponsors and Collaborators
Heidelberg University
  More Information Identifier: NCT00917202     History of Changes
Other Study ID Numbers: S-237/2007
Study First Received: June 9, 2009
Last Updated: June 9, 2009

Additional relevant MeSH terms:
Protozoan Infections
Parasitic Diseases
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 24, 2017