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Antimicrobial Agents and Chemotherapy, July 2003, p. 2199-2203, Vol. 47, No. 7
0066-4804/03/$08.00+0     DOI: 10.1128/AAC.47.7.2199-2203.2003

Tolerability of Azithromycin as Malaria Prophylaxis in Adults in Northeast Papua, Indonesia

Walter R. Taylor,^1,2* Thomas L. Richie,¹ David J. Fryauff,¹ Colin Ohrt,³ Helena Picarima,¹ Douglas Tang,⁴ Gerald S. Murphy,¹ Hendra Widjaja,¹ David Braitman,⁵ Emiliana Tjitra,⁶ Asep Ganjar,⁷ Trevor R. Jones,¹ Hasan Basri,¹ and Josh Berman³

U.S. Naval Medical Research Unit No. 2,¹ Centre for Health Research and Development, National Institutes of Health, Jakarta,⁶ District Military Health Services, Jayapura, Papua, Indonesia,⁷ Department of Tropical Medicine, Tulane University School of Public Health, New Orleans, Louisiana,² Division of Experimental Therapeutics,³ Division of Biometrics, Walter Reed Army Institute of Research, Washington, D.C.,⁴ U.S. Army Medical Materiel Development Activity, Fort Detrick, Maryland⁵

Received 25 October 2002/ Returned for modification 13 January 2003/ Accepted 3 April 2003

Drug tolerability affects compliance. We evaluated the tolerability levels of azithromycin (750-mg loading dose plus 250 mg/day; n = 148 subjects), doxycycline (100 mg/day; n = 75), and placebo (n = 77) as prophylaxis against malaria in Indonesian adults over 20 weeks. Self-reported and elicited symptoms, health perception, hearing, hematology, and biochemistry were assessed. The loading dose was well tolerated. The frequencies (number per person-years [p-yr]) of all daily reported symptoms were similar in the three arms of the study: 40.2/p-yr for azithromycin, 39.7/p-yr for doxycycline, and 38.2/p-yr for placebo. Relative to those who received placebo, azithromycin recipients complained more often of heartburn (rate ratio = 10.5 [95% confidence interval, 2.8 to 88.1]), paresthesia (2.03 [1.08 to 4.24]), and mild (1.55 [1.01 to 2.48]) and severe (11.2 [1.34 to ]) itching but less often of fever (0.21 [0.09 to 0.49]) and tinnitus (0.09 [0.04 to 0.21]). Azithromycin recipients showed no evidence of clinical hearing loss or hematologic, hepatic, or renal toxicity. One azithromycin recipient developed an erythematous rash. Daily azithromycin was well tolerated by these Indonesian adults during 20 weeks of treatment.

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* Corresponding author. Mailing address: WHO/TDR/PRD, Avenue Appia, CH1211, Geneva 27, Switzerland. Phone: 41-22-791-3853. Fax: 41-22-791-4774. E-mail: taylorw{at}who.ch.

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Antimicrobial Agents and Chemotherapy, July 2003, p. 2199-2203, Vol. 47, No. 7
0066-4804/03/$08.00+0     DOI: 10.1128/AAC.47.7.2199-2203.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.

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