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NCT Number: NCT00917202

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

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.

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Key information

Conditions

Malaria Infections Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

17 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Nouna Health District

Nouna, Burkina Faso

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methylenblue

Drug

Primary outcomes

  1. Adequate clinical and parasitolgical response (ACPR) until D 28

Secondary outcomes

  1. Early treatment failure (ETF) rate

  2. Late clinical failure (LCF) rate at D14 and D28

  3. Late parasitological failure (LPF) rate at D14 and D28

  4. Fever clearance time

  5. Parasite clearance time

  6. Change in haematocrit after 2,3,7,14 and 28 days compared to baseline

  7. Incidence of observed and self-reported non-serious adverse events over the 28 days observation period

  8. Incidence of serious adverse events over the 28 days observation period

  9. MB whole blood concentrations (trough concentrations) on day 3,5 or 7 compared to trough concentrations after the first dose

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Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Registry information

Official study 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

Important dates

First posted
Jun 10, 2009
Registry last updated
Jun 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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