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Treatment outcome of intravenous artesunate in patients with severe malaria in the Netherlands and Belgium

Annemarie R Kreeftmeijer-Vegter12*, Perry J van Genderen3, Leo G Visser4, Wouter FW Bierman5, Jan Clerinx6, Cees KW van Veldhuizen2 and Peter J de Vries1

Author Affiliations

1 Department of Internal Medicine, Division of Infectious Diseases, Academic Medical Center, Meibergdreef 9, 1105AZ Amsterdam, the Netherlands

2 ACE Pharmaceuticals B.V., Schepenveld 41, 3891 ZK Zeewolde, the Netherlands

3 Department of Internal Medicine, Harbour Hospital and Institute for Tropical Diseases, Haringvliet 72, 3011 TG Rotterdam, the Netherlands

4 Department of Infectious Disease, Section Travel Medicine, Leiden University Medical Centre, Albinusdreef 2, 2333 ZA Leiden, the Netherlands

5 Department of Internal Medicine, University Medical Centre Groningen, Hanzeplein 1, 9713 GZ Groningen, the Netherlands

6 Department of Clinical Sciences, Institute of Tropical Medicine Antwerp, Nationalestraat 155 B, 2000 Antwerp, Belgium

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Malaria Journal 2012, 11:102  doi:10.1186/1475-2875-11-102

Published: 31 March 2012

Abstract

Background

Intravenous (IV) artesunate is the treatment of choice for severe malaria. In Europe, however, no GMP-manufactured product is available and treatment data in European travellers are scarce. Fortunately, artesunate became available in the Netherlands and Belgium through a named patient programme. This is the largest case series of artesunate treated patients with severe malaria in Europe.

Methods

Hospitalized patients treated with IV artesunate between November 2007 and December 2010 in the Netherlands and Belgium were retrospectively evaluated. Patient characteristics, treatment and clinical outcome were recorded on a standardized form and mortality, parasite clearance times and the occurrence of adverse events were evaluated.

Results

Of the 68 treated patients, including 55 with severe malaria, two patients died (2/55 = 3.6%). The mean time to 50% parasite clearance (PCT50), 90% and 99% were 4.4 hours (3.9 - 5.2), 14.8 hours (13.0 - 17.2), and 29.5 hours (25.9 - 34.4) respectively. Artesunate was well tolerated. However, an unusual form of haemolytic anaemia was observed in seven patients. The relationship with artesunate remains uncertain.

Conclusions

Data from the named patient programme demonstrate that IV artesunate is effective and well-tolerated in European travellers lacking immunity. However, increased attention needs to be paid to the possible development of haemolytic anaemia 2-3 weeks after start of treatment.

Treatment of IV artesunate should be limited to the period that IV treatment is required and should be followed by a full oral course of an appropriate anti-malarial drug.

Keywords:
Intravenous artesunate; Severe malaria; Parasite clearance; Named patient program; European traveller