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SULFADOXINE-PYRIMETHAMINE PLUS CHLOROQUINE OR AMODIAQUINE FOR UNCOMPLICATED FALCIPARUM MALARIA: A RANDOMIZED, MULTISITE TRIAL TO GUIDE NATIONAL POLICY IN UGANDA

The use of combinations of inexpensive drugs for the treatment of malaria in Africa has been proposed as an interim policy while awaiting the widespread availability of more effective regimens. We compared sulfadoxine-pyrimethamine plus chloroquine or amodiaquine in three districts in Uganda. Patients aged 6 months or greater with uncomplicated falciparum malaria were enrolled and randomized to therapy. Safety, tolerability, and efficacy outcomes, adjusted by genotyping, were assessed over 28 days. Of 1,105 patients enrolled, 1,057 (96%) completed follow-up. For children less than 5 years old, the risk of clinical treatment failure adjusted by genotyping at the three sites ranged from 34% to 67% with chloroquine plus sulfadoxine-pyrimethamine and from 13% to 35% with amodiaquine plus sulfadoxine-pyrimethamine (risk differences 21–32%, P < 0.0001 at all sites). Serious adverse events were uncommon with both regimens. The risk of treatment failure with chloroquine plus sulfadoxine-pyrimethamine, the current standard in Uganda, was unacceptably high. Amodiaquine plus sulfadoxine-pyrimethamine was significantly more efficacious; however, existing levels of resistance raises concern about the useful therapeutic life-span of this regimen.

Received May 19, 2004. Accepted for publication October 19, 2004.

Acknowledgments: The authors thank the clinical study team of Joy Bbosa, Nelson Budaka, Oswald Byaruhanga, Moses Musinguzi, Isaac Kigozi, Felix Jurua, Richard Allen, Jonathan Vlahos, Fred Kizito, and Grace Musimenta. We would also like to thank Moses Kigundu, Dan Kyabainze and Regina Nakafero for training the laboratory staff and providing laboratory quality control. We would also like to thank all the health workers at the health centers of Kasambya (Mubende district), Kyenjojo (Kyenjojo district) and Kihihi (Kanungu district), and their respective district administrations, for allowing us to conduct these studies and working alongside the study teams for lengthy periods. We are indebted to the administrative support of Sara Kibirango, Kenneth Mwebaze, and drivers Nuhu Kibampawo, Joshua Sekitoleko, and Marx Dongo who worked tirelessly for the success of these studies. Special thanks goes to John Mpindi the data officer for his tenacity when entering the data and his constant assistance with the data management and Heidi Hopkins who periodically helped with data management and also gave useful comments during the preparation of the manuscript.

Financial support: This work was supported by the Centers for Disease Control/Association Schools of Public Health cooperative agreement, "Malaria Surveillance and Control in Uganda" (SA3569 & S1932-21/21), and the Department for International Development (DFID).

Authors’ addresses: Nathan Bakyaita, Adoke Yeka, Ambrose Talisuna, and Albert Kilian, Ministry of Health/UMSP, P.O. Box 7475, Kampala, Uganda, Telephone: 011-256-41-231563/231569, Fax: 011-256-41-540524. Grant Dorsey, Kristin Banek, Sarah G. Staedke, and Philip J. Rosenthal, University of California, San Francisco, Parnassus Avenue, Box 0811, San Francisco, CA 94143, Telephone: 415-648-4680, Fax: 415-648-8425. Moses R. Kamya, Fred Kironde, and Sam Nsobya, Makerere University Medical School, P.O. Box 7072, Kampala, Uganda, Telephone: 011-256-41-541188, Fax: 011-256-41-540524. Arthur Reingold, University of California, Berkeley School of Public Health, Department of Epidemiology, 140 Warren Hall, MC#7360, Berkeley, CA 94720, Telephone: 510-642-0327, Fax: 510-643-5163. Fred Wabwire-Mangen, Makerere University Institute of Public Health, P.O. Box 7072, Kampala, Uganda, Telephone: 011-256-41-532207, Fax: 011-256-41-531807.

Reprint requests: Nathan Bakyaita, Ministry of Health/UMSP, P.O. Box 7475, Kampala, Uganda, Telephone: Office +256 41 231563/9 Ext 249, Cell +256 77 601579, Fax: +256 41 540524, E-mail: nbakyaita{at}yahoo.com.

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