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BMJ Glob Health. 2017 Aug 30;2(3):e000371. doi: 10.1136/bmjgh-2017-000371. eCollection 2017.

Randomised controlled trial of two sequential artemisinin-based combination therapy regimens to treat uncomplicated falciparum malaria in African children: a protocol to investigate safety, efficacy and adherence.

BMJ global health

Henk Dfh Schallig, Halidou Tinto, Patrick Sawa, Harparkash Kaur, Stephan Duparc, Deus S Ishengoma, Pascal Magnussen, Michael Alifrangis, Colin J Sutherland

Affiliations

  1. Department of Medical Microbiology-Parasitology Unit, Academic Medical Centre, Amsterdam, The Netherlands.
  2. Institute for Health Sciences Research-Clinical Research Unit (IRSS-CRUN), Nanoro, Burkina Faso.
  3. International Centre for Insect Physiology and Ecology, Mbita Point, Kenya.
  4. Clinical Research Department, Faculty of Infectious & Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK.
  5. Immunology & Infection Department, Faculty of Infectious & Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK.
  6. Medicines for Malaria Venture, Geneva, Switzerland.
  7. National Institute for Medical Research, Tanga, Tanzania.
  8. Department of International Health, Immunology and Microbiology, Centre for Medical Parasitology, University of Copenhagen, Copenhagen, Denmark.
  9. Department of Infectious Diseases, Rigshospitalet, Copenhagen, Denmark.
  10. Public Health England Malaria Reference Laboratory, London School of Hygiene & Tropical Medicine, London, UK.

PMID: 29082016 PMCID: PMC5656137 DOI: 10.1136/bmjgh-2017-000371

Abstract

BACKGROUND: Management of uncomplicated

METHODS: We present an open-label, randomised three-arm clinical trial protocol in three African settings representative of varying malaria epidemiology to investigate whether prolonged ACT-based regimens using currently available formulations can eliminate potentially resistant parasites. The protocol investigates whether a sequential course of two licensed ACT in 1080 children aged 6-120 months exhibits superior efficacy against acute

DISCUSSION: This protocol addresses efficacy and safety of sequential ACT regimens in

Keywords: malaria; randomised control trial

Conflict of interest statement

Competing interests: None declared.

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