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.
Heppner
D Gray
DG
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
Walsh
Douglas S
DS
Uthaimongkol
Nichapat
N
Tang
Douglas B
DB
Tulyayon
Somchit
S
Permpanich
Barnyen
B
Wimonwattrawatee
Theera
T
Chuanak
Niphon
N
Laoboonchai
Anintita
A
Sookto
Prasit
P
Brewer
Thomas G
TG
McDaniel
Philip
P
Eamsila
Chirapa
C
Yongvanitchit
Kosol
K
Uhl
Kathleen
K
Kyle
Dennis E
DE
Keep
Lisa W
LW
Miller
Robert E
RE
Wongsrichanalai
Chansuda
C
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
D000962:Antimalarials; D017963:Azithromycin