title: Randomized, controlled, double-blind trial of daily oral azithromycin in adults for the prophylaxis of Plasmodium vivax malaria in Western Thailand.
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.
authors.affiliation: 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
authors.forename: D Gray
authors.initials: DG
authors.lastname: Heppner
authors.forename: Douglas S
authors.initials: DS
authors.lastname: Walsh
authors.forename: Nichapat
authors.initials: N
authors.lastname: Uthaimongkol
authors.forename: Douglas B
authors.initials: DB
authors.lastname: Tang
authors.forename: Somchit
authors.initials: S
authors.lastname: Tulyayon
authors.forename: Barnyen
authors.initials: B
authors.lastname: Permpanich
authors.forename: Theera
authors.initials: T
authors.lastname: Wimonwattrawatee
authors.forename: Niphon
authors.initials: N
authors.lastname: Chuanak
authors.forename: Anintita
authors.initials: A
authors.lastname: Laoboonchai
authors.forename: Prasit
authors.initials: P
authors.lastname: Sookto
authors.forename: Thomas G
authors.initials: TG
authors.lastname: Brewer
authors.forename: Philip
authors.initials: P
authors.lastname: McDaniel
authors.forename: Chirapa
authors.initials: C
authors.lastname: Eamsila
authors.forename: Kosol
authors.initials: K
authors.lastname: Yongvanitchit
authors.forename: Kathleen
authors.initials: K
authors.lastname: Uhl
authors.forename: Dennis E
authors.initials: DE
authors.lastname: Kyle
authors.forename: Lisa W
authors.initials: LW
authors.lastname: Keep
authors.forename: Robert E
authors.initials: RE
authors.lastname: Miller
authors.forename: Chansuda
authors.initials: C
authors.lastname: Wongsrichanalai
mesh_terms: D000328:Adult; D000818:Animals; D000962:Antimalarials / Q000008:administration & dosage / Q000627:therapeutic use*; D017963:Azithromycin / Q000008:administration & dosage / Q000627:therapeutic use*; D018890:Chemoprevention; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D016780:Malaria, Vivax / Q000453:epidemiology / Q000469:parasitology / Q000517:prevention & control*; D008297:Male; D018512:Parasitemia / Q000453:epidemiology / Q000469:parasitology / Q000517:prevention & control*; D010966:Plasmodium vivax / Q000187:drug effects; D013785:Thailand / Q000453:epidemiology; D016896:Treatment Outcome
chemical_list: D000962:Antimalarials; D017963:Azithromycin