Abstract
BackgroundCerebral 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.MethodsAn 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.Results35 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.ConclusionThese 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 numberClinicalTrials.gov ID: NCT00697164
Highlights
Cerebral malaria carries an unacceptable case fatality rate in children despite timely and adequate chemotherapy
Ethical approval was obtained from the Institutional Review Board (IRB) of the Faculty of Medicine, Pharmacy and Dentistry of Bamako, and from the board of trustees of Roche Foundation for Anaemia Research (RoFAR)
Baseline characteristics Overall, 35 patients were included in the study between October 2007 and September 2008. 28 patients received full treatment including three doses of Epo at 1,500 UI/kg combined with quinine and completed follow-up according to the protocol
Summary
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. Most adjunctive therapies tested in human cerebral malaria were focussed on the modulation of the inflammatory response [2]. It was highlighted that most of these studies were underpowered [6] In some cases, these adjunctive drugs were responsible for deleterious effects and trials were suspended [7]. There is a growing evidence for this concept of cell protection during acute ischemic diseases [12,13]
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