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DESCRIPTIVE STUDY ON THE EFFICACY AND SAFETY OF ARTESUNATE SUPPOSITORY IN COMBINATION WITH OTHER ANTIMALARIALS IN THE TREATMENT OF SEVERE MALARIA IN SUDAN

Documentation on the efficacy of artesunate in Africa is limited, and no experience of artesunate use in Sudan is documented. Severe malaria in rural areas of Sudan, where facilities for the safe and effective use of parenteral quinine are lacking, is a frequent problem. Early treatment with artesunate suppositories would provide a simple method for use by unskilled staff and would be an alternative approach to treat malaria in settings with poor resources. We describe a hospital-based study of rectal artesunate in 100 adult patients with severe falciparum malaria with a dose derived from pharmacokinetic data (200 mg every 8 hours) over 3 days, which halted progression of severe disease and had a low fatality rate. The dosage schedule led to a rapid clinical response and reduced parasite clearance and fever subsidence times of (31.5 ± 10.1 hours) and (31.4 ± 11.1 hours). The sequential treatment of rectal artesunate with either doxycycline or pyrimethamine/sulfadoxine or mefloquine resulted in similar clinical cure rates of around 100%, and the combination of artesunate with either doxycycline or pyrimethamine/sulfadoxine was equally effective as mefloquine in preventing recrudescence. There were no significant adverse effects or signs of toxicity related to the treatment observed during the 28-day follow-up. The combination regimens could be used in areas where there is limited access to parenteral therapy for malaria.

Received April 23, 2002. Accepted for publication October 14, 2002.

Acknowledgments: We deeply thank all the medical staff in Omdurman Teaching Hospital and Tropical Disease Hospital, particularly Dr. Omer Nemiri, Dr. Fatima A., Dr. Angal Almahdi, and Dr. Amel Hajnour, for their assistance and collaboration in carrying out the clinical trial. We thank Mr Tarig Elfaki, Mr Salah G. Elzaki, Mr. Mohamed A/gadir, and Mr. Afiefi, for their technical assistance throughout this work.

Financial support: This work was supported by the British Chevening Scholarship, University of Khartoum, Tropical Research Institute, and Malaria National Administration in Sudan. We thank Mepha Pharmaceutical Research, Aesch-Basel, Switzerland, for the donation of artesunate rectocaps.

The clinical trials were conducted in Khartoum-Sudan. Data interpretation and writing were undertaken at Robert Gordon University, United Kingdom, and University of Khartoum, Sudan.

Authors’ addresses: M. I. Awad and I. B. Eltayeb, Department of Pharmacology, Faculty of Pharmacy, University of Khartoum, P.O. Box 1996, Khartoum, Sudan. A. M. Y. Alkadru and O. Z. Baraka, Department of Internal Medicine and Applied Therapeutics, Faculty of Medicine, University of Khartoum, P.O. Box 1063, Khartoum, Sudan. R. H. Behrens, Department of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, Keppel Street, London, UK, Telephone: +44 207 9272661, E-mail: ron.behrens{at}lshtm.ac.uk

Reprint requests: R. H. Behrens, Department of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, Keppel Street, London, UK, Telephone: +44 207 9272661, E-mail: ron.behrens{at}lshtm.ac.uk

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