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

June 9, 2009 updated by: Heidelberg University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 55 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MB3
3 days
Drug: Methylenblue
Experimental: MB5
5 days
Drug: Methylenblue
Experimental: MB7
Drug: Methylenblue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Adequate clinical and parasitolgical response (ACPR) until D 28

Secondary Outcome Measures

Outcome Measure
Parasite clearance time
Fever clearance time
Early treatment failure (ETF) rate
Late clinical failure (LCF) rate at D14 and D28
Late parasitological failure (LPF) rate at D14 and D28
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

June 9, 2009

First Submitted That Met QC Criteria

June 9, 2009

First Posted (Estimate)

June 10, 2009

Study Record Updates

Last Update Posted (Estimate)

June 10, 2009

Last Update Submitted That Met QC Criteria

June 9, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-237/2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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