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

June 9, 2009
June 9, 2009
Not Provided
Not Provided
Adequate clinical and parasitolgical response (ACPR) until D 28
Same as current
No Changes Posted
  • 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
Same as current
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 2
Not Provided
Malaria
Drug: Methylenblue
  • Experimental: MB3
    3 days
    Intervention: Drug: Methylenblue
  • Experimental: MB5
    5 days
    Intervention: Drug: Methylenblue
  • Experimental: MB7
    Intervention: Drug: Methylenblue
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
Not Provided

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
Male
17 Years to 55 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
Burkina Faso
 
NCT00917202
S-237/2007
Not Provided
Not Provided
Heidelberg University
Not Provided
Not Provided
Heidelberg University
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP