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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

Primary Purpose

Malaria

Status

Completed

Phase

Phase 2

Locations

Burkina Faso

Study Type

Interventional

Intervention

Methylenblue

About this trial

This is an interventional trial for Malaria

Eligibility Criteria

17 Years - 55 Years (Child, Adult)Male

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

Sites / Locations

Nouna Health District

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

MB3

MB5

MB7

Arm Description

3 days

5 days

Outcomes

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

Full Information

NCT ID

NCT00917202

First Posted

June 9, 2009

Last Updated

June 9, 2009

Sponsor

Heidelberg University

1. Study Identification

Unique Protocol Identification Number

NCT00917202

Brief 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 Project of the SFB 544

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2009

Overall Recruitment Status

Completed

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Heidelberg University

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malaria

7. Study Design

Study Phase

Phase 2

8. Arms, Groups, and Interventions

Arm Title

MB3

Arm Type

Experimental

Arm Description

3 days

Arm Title

MB5

Arm Type

Experimental

Arm Description

5 days

Arm Title

MB7

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Methylenblue

Primary Outcome Measure Information:

Title

Adequate clinical and parasitolgical response (ACPR) until D 28

Secondary Outcome Measure Information:

Title

Early treatment failure (ETF) rate

Title

Late clinical failure (LCF) rate at D14 and D28

Title

Late parasitological failure (LPF) rate at D14 and D28

Title

Fever clearance time

Title

Parasite clearance time

Title

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

Title

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

Title

Incidence of serious adverse events over the 28 days observation period

Title

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

17 Years

Maximum Age & Unit of Time

55 Years

Eligibility 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

Facility Information:

Facility Name

Nouna Health District

City

Nouna

Country

Burkina Faso

12. IPD Sharing Statement

Learn more about this trial

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

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