Randomized, controlled, double-blind trial of daily oral azithromycin in adults for the prophylaxis of Plasmodium vivax malaria in Western Thailand |
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Authors: | Heppner D Gray Walsh Douglas S Uthaimongkol Nichapat Tang Douglas B Tulyayon Somchit Permpanich Barnyen Wimonwattrawatee Theera Chuanak Niphon Laoboonchai Anintita Sookto Prasit Brewer Thomas G McDaniel Philip Eamsila Chirapa Yongvanitchit Kosol Uhl Kathleen Kyle Dennis E Keep Lisa W Miller Robert E Wongsrichanalai Chansuda |
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Institution: | Department of Immunology and Medicine, United States Army Medical Component, Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand. donald.heppner@na.amedd.army.mil |
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Abstract: | 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. |
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