Efficacy of methylene blue monotherapy in semi-immune adults with uncomplicated falciparum malaria: a controlled trial in Burkina Faso.

Abstract

OBJECTIVE:

To assess the efficacy of methylene blue (MB) monotherapy in semi-immune adults with uncomplicated malaria in Burkina Faso.

METHODS:

In an open-label controlled phase II study with 60 semi-immune adults with uncomplicated falciparum malaria in Nouna, north-western Burkina Faso, MB monotherapy (390 mg twice daily) was given sequentially to groups of 20 adults for 7 days (MB7), 5 days (MB5) and 3 days (MB3), respectively. The primary outcome was the rate of adequate clinical and parasitological response (ACPR) on day 28 of follow-up.

RESULTS:

Of the study population, 27/58 (47%) and 5/51 (10%) patients still had parasites on days 2 and 3, respectively, of follow-up resulting in 9/58 (16%) early treatment failures. By day 14, no recrudescence was observed but in 4/19 (MB5) and 2/20 (MB3) individuals by day 28. The PCR-corrected rate of ACPR was 72%, 58% and 85% in groups 7, 5 and 3, respectively, by per protocol analysis. Self-limiting dysuria was the most frequent adverse event.

CONCLUSIONS:

MB acts slowly against the blood stages of P. falciparum. MB alone needs to be given for at least 7 days to be efficacious in the treatment of falciparum malaria but should be used in combination with a fast acting antimalarial.

• Authors: Mamadou Bountogo, Augustin Zoungrana, Boubacar Coulibaly, Christina Klose, Ulrich Mansmann, Frank P Mockenhaupt, Jürgen Burhenne, Gerd Mikus, Ingeborg Walter-Sack, R Heiner Schirmer, Ali Sié, Peter Meissner, Olaf Müller
• Journal: Tropical medicine & international health : TM & IH (Trop Med Int Health) Vol. 15 Issue 6 Pg. 713-7 (Jun 2010) ISSN: 1365-3156 [Electronic] England
• PMID: 20374561 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Antimalarials
• Enzyme Inhibitors
• Methylene Blue

Topics

• Adolescent
• Adult
• Antimalarials (adverse effects, therapeutic use)
• Burkina Faso
• Drug Administration Schedule
• Dysuria (etiology)
• Enzyme Inhibitors (adverse effects, therapeutic use)
• Female
• Humans
• Malaria, Falciparum (drug therapy)
• Male
• Methylene Blue (adverse effects, therapeutic use)
• Middle Aged
• Plasmodium falciparum (isolation & purification)
• Polymerase Chain Reaction
• Single-Blind Method
• Young Adult