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.
Sponsor:
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00917202
First received: June 9, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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
Malaria
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

  Eligibility

Ages Eligible for Study:   17 Years to 55 Years
Genders Eligible for Study:   Male
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
  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 ClinicalTrials.gov identifier: NCT00917202

Locations
Burkina Faso
Nouna Health District
Nouna, Burkina Faso
Sponsors and Collaborators
Heidelberg University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00917202     History of Changes
Other Study ID Numbers: S-237/2007
Study First Received: June 9, 2009
Last Updated: June 9, 2009
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014