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Safety of epoietin beta-quinine drug combination in children with cerebral malaria in Mali

Stéphane Picot1,2 email, Anne-Lise Bienvenu1,2 email, Salimata Konate3 email, Sibiri Sissoko3 email, Abdoulaye Barry3 email, Elisabeth Diarra3 email, Karidiatou Bamba3 email, Abdoulaye Djimdé3 email and Ogobara K Doumbo3 email

Malaria Research Unit, EA 4170, University Lyon 1, Faculty of Medicine, 8 avenue Rockefeller, 69373 Lyon, France

Paludisme, parasites du sang et mycologie médicale, Hospices Civils de Lyon, Lyon, France

Malaria Research and training Center, Department of Epidemiology of Parasitic Diseases, Faculty of Medicine, Pharmacy and Dentistry, University of Bamako, Mali

author email corresponding author email

Malaria Journal 2009, 8:169doi:10.1186/1475-2875-8-169

Published: 24 July 2009

Abstract

Background

Cerebral malaria carries an unacceptable case fatality rate in children despite timely and adequate chemotherapy. To improve the survival rate, adjunctive therapies previously tested mainly focused on the modulation of the inflammatory response, without definitive effect in humans. In this context, a new adjunctive strategy using a neuroprotective drug: erythropoietin (epoietin-beta, Epo) was proposed.

Methods

An open-labelled study including cerebral malaria children (Blantyre coma score below 3) was conducted in Mali. The objective was to assess the short-term safety (seven days) of erythropoietin at high doses (1,500 U/kg/day during three days) combined to quinine.

Results

35 patients with unrousable coma were included in the study. None of expected side effects of erythropoietin were observed during the seven days follow-up. No significant increase in the case fatality rate (7/35 patients) was observed compared to other studies with mortality rates ranging from 16 to 22% in similar endemic areas.

Conclusion

These data provide the first evidence of the short-term safety of erythropoietin at high doses combined to quinine. A multicentre study is needed to assess the potential of Epo as an adjunctive therapy to increase the survival during cerebral malaria.

Clinical registration number

ClinicalTrials.gov ID: NCT00697164


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