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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

Completed Phase 2 Last updated 9 June 2009
What this trial tests

Phase 2 trial testing Methylenblue in Malaria. Completed.

Quick facts

Lead sponsorHeidelberg University
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Sites1 location across Burkina Faso

Drugs / interventions tested

Conditions studied

Sponsor

Heidelberg University

Who can join

Adults 17 to 55, male only, with Malaria.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Beyond the margins: real-time detection of cancer using targeted fluorophores.
    Zhang RR, Schroeder AB, Grudzinski JJ, Rosenthal EL, et al · · 2017 · cited 321× · PMID 28094261 · DOI 10.1038/nrclinonc.2016.212

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Other recruiting trials for Malaria

Currently open trials in the same condition.

Other Heidelberg University trials

Trials by the same sponsor.

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