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J Infect Dis. 2015 Mar 1;211(5):689-97. doi: 10.1093/infdis/jiu540. Epub 2014 Sep 28.

Efficacy and safety of triple combination therapy with artesunate-amodiaquine-methylene blue for falciparum malaria in children: a randomized controlled trial in Burkina Faso.

Author information

1
Centre de Recherche en Santé de Nouna, Nouna.
2
Division of Infectious Diseases and Tropical Medicine, Medical Center Department of Bacteriology, Max von Pettenkofer-Institute, Ludwig Maximilian University of Munich German Center for Infection Research, Partner Site Munich.
3
Department of Pediatrics and Adolescent Medicine, Medical School, Ulm University.
4
Institute of Medical Biometry and Informatics.
5
Division of Infectious Diseases and Tropical Medicine, Medical Center.
6
Centre de Recherche et de la Formation au Paludisme, Ouagadougou, Burkina Faso.
7
Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University Düsseldorf.
8
Biochemistry Centre, Ruprecht-Karls-University, Heidelberg.
9
Institute of Tropical Medicine and International Health, Charité-Universitätsmedizin Berlin, Germany.
10
Department of Immunology & Infection, London School of Tropical Medicine and Hygiene, United Kingdom.
11
Department of Immunology & Infection, London School of Tropical Medicine and Hygiene, United Kingdom Department of Medical Microbiology, Radboud University Medical Center, Nijmegen, the Netherlands.
12
Institute of Public Health, Medical School.

Abstract

BACKGROUND:

Methylene blue (MB) has been shown to be safe and effective against falciparum malaria in Africa and to have pronounced gametocytocidal properties.

METHODS:

Three days of treatment with artesunate (AS)-amodiaquine (AQ) combined with MB was compared with AS-AQ treatment in a randomized controlled phase IIb study; the study included 221 children aged 6-59 months with uncomplicated falciparum malaria in Burkina Faso. The primary end point was gametocyte prevalence during follow-up, as determined by microscopy and real-time quantitative nucleic acid sequence-based amplification (QT-NASBA).

RESULTS:

The gametocyte prevalence of Plasmodium falciparum at baseline was 3.6% (microscopy) and 97% (QT-NASBA). It was significantly lower in the AS-AQ-MB than in the AS-AQ group on day 7 of follow-up (microscopy, 1.2% vs 8.9% [P < .05]; QT-NASBA, 36.7% vs 63.3% [P < .001]). Hemoglobin values were significantly lower in the AS-AQ-MB group than in the AS-AQ group at days 2 and 7 of follow-up. Vomiting of the study medication occurred significantly more frequently in the AS-AQ-MB group.

CONCLUSIONS:

The combination of MB with an artemisinin-based combination therapy has been confirmed to be effective against the gametocytes of P. falciparum. MB-based combinations need to be compared with primaquine-based combinations, preferably using MB in an improved pediatric formulation. Clinical Trials Registration: NCT01407887.

KEYWORDS:

Africa; gametocytes; malaria; methylene blue

PMID:
25267980
DOI:
10.1093/infdis/jiu540
[Indexed for MEDLINE]

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