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RANDOMIZED, CONTROLLED, DOUBLE-BLIND TRIAL OF DAILY ORAL AZITHROMYCIN IN ADULTS FOR THE PROPHYLAXIS OF PLASMODIUM VIVAX MALARIA IN WESTERN THAILAND

We assessed the prophylactic efficacy of azithromycin (250 mg/day) against malaria in 276 adults in western Thailand in a randomized, double-blind, placebo-controlled trial. After antimalarial suppressive treatment, volunteers were randomized in a 2:1 ratio to either the azithromycin or placebo, respectively. Study medication was given for an average of 74 days. The azithromycin group (n = 179) had five endpoint parasitemias (1 Plasmodium vivax and 4 P. falciparum), and the placebo group (n = 97) had 28 endpoint parasitemias (21 P. vivax, 5 P. falciparum, and 2 mixed infections). Adverse events and compliance and withdrawal rates were similar in both groups. The protective efficacy (PE) of azithromycin was 98% for P. vivax (95% confidence interval [CI] = 88–100%). There were too few cases to reliably estimate the efficacy of azithromycin for P. falciparum (PE =71%, 95% C =–14–94%). We conclude that daily azithromycin was safe, well-tolerated, and had a high efficacy for the prevention of P. vivax malaria.

Received April 18, 2005. Accepted for publication June 2, 2005.

Acknowledgments: We thank the following individuals for their contributions to the study: Dr. Ladaporn Bodhidatta and Marianne Weijers for clinical assistance; Dr. Scott Gordon for characterization of the malaria vectors; Khun Prapatsorn Ngaowichit for logistical support at the field site; Dr. Krongthong Thimasarn (Thai Ministry of Public Health) for administrative support; Suchai Kitsiripornchai (Royal Thai Army) and Dr. Brian Schuster and Dr. Jonathan Berman (Walter Reed Army Institute of Research) for scientific consultations; Dr. David Braitman (United States Army Medical Materiel Development Activity) for funding and regulatory guidance; and Al Skudnik (Walter Reed Army Medical Center) for preparation of the test articles. This work was presented in part at the 49th Annual Meeting of the American Society of Tropical Medicine and Hygiene Annual, Washington, DC, November 1999 (Abstract no. 25).

Financial support: This study was supported by the United States Army Medical Materiel Development Activity and by the Military Infectious Diseases Research Program (Fort Detrick, Frederick, MD).

Disclaimer: The opinions and assertions presented here are the private views of the authors and not to be construed as reflecting the views of the United States Departments of Defense or Army.

Disclosure: None of the authors has any conflicts of interest.

^* Address correspondence to D. Gray Heppner, Jr., Walter Reed Army Institute of Research, 503 Robert Grant Avenue, Silver Spring, MD 20910. E-mail: donald.heppner{at}na.amedd.army.mil

Authors’ addresses: D. Gray Heppner, Jr., Douglas S. Walsh, Douglas B. Tang, and Dennis E. Kyle, Walter Reed Army Institute of Research, 503 Robert Grant Avenue, Silver Spring, MD 20910, Telephone: 301 - 319 - 9414, Fax: 301 - 319 - 7358 , E-mail: donald.heppner{at}na.amedd.army.mil. Nichapat Uthaimongkol, Somchit Tulyayon, Barnyen Permpanich, Theera Wimonwattrawatee, Niphon Chuanak, Anintita Laoboonchai, Prasit Sookto, and Kosol Yongvanitchit, United States Army Medical Component, Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand, AP APO 96546. Thomas G. Brewer, Bill & Melinda Gates Foundation, P. O. Box 23350, Seattle, WA 98102, E-mail: thomasb{at}gatesfoundation.org. Philip McDaniel, 10803 SE Cherry Blossom Drive, Portland, OR 97216 - 3107, E-mail: philmcd{at}concentric.net. Chirapa Eamsila, Research Division, Thai Component, Armed Forces Research Institute of Medical Sciences, 315/6 Rajavithi Road, Bangkok 10400, Thailand, E-mail: chirapa.eamsila{at}amedd.army.mil. Kathleen Uhl, U.S. Food and Drug Administration Center for Drug Evaluation and Research, Office of New Drugs, 5600 Fishers Lane, HFD-020, Rockville, MD 20857, Telephone: 301-443-5157, Fax: 301-443-5515, E-mail: uhlk{at}cder.fda.gov. Lisa W. Keep, Department of Preventive Medicine, Uniformed Services University of the Health Sciences, 4301 Jones Bridge Road, Bethesda, MD 20814, E-mail: lkeep{at}usuhs.mil. Robert E. Miller, L-3 Government Services, Inc., 1003 West 7th, Suite 506, Frederick, MD 21701, E-mail: DrBob2{at}adelphia.net. Chansuda Wongsrichanalai, National Institute of Public Health/ Naval Medical Research Unit 2 Laboratory, P.O. Box 131, Phnom Penh, Cambodia, E-mail: chansuda{at}namru2.med.navy.mil.

Reprint requests: D. Gray Heppner Jr., Walter Reed Army Institute of Research, 503 Robert Grant Avenue, Silver Spring, MD 20910.

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