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

Malaria Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00917202
• Other study ID #: S-237/2007
• Status: Completed
• Phase: Phase 2
• First received: June 9, 2009
• Last updated: June 9, 2009

Study information

• Verified date: June 2009
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Gender: Male
• Age group: 17 Years to 55 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• Methylenblue

Locations

Country	Name	City	State
Burkina Faso	Nouna Health District	Nouna

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Burkina Faso, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adequate clinical and parasitolgical response (ACPR) until D 28
Secondary	Early treatment failure (ETF) rate
Secondary	Late clinical failure (LCF) rate at D14 and D28
Secondary	Late parasitological failure (LPF) rate at D14 and D28
Secondary	Fever clearance time
Secondary	Parasite clearance time
Secondary	Change in haematocrit after 2,3,7,14 and 28 days compared to baseline
Secondary	Incidence of observed and self-reported non-serious adverse events over the 28 days observation period
Secondary	Incidence of serious adverse events over the 28 days observation period
Secondary	MB whole blood concentrations (trough concentrations) on day 3,5 or 7 compared to trough concentrations after the first dose