Traveler's Diarrhea in Thailand: Randomized, Double-Blind Trial Comparing Single-Dose and 3-Day Azithromycin-Based Regimens with a 3-Day Levofloxacin Regimen.
Tribble, David R. 1; Sanders, John W. 2; Pang, Lorrin W. 6; Mason, Carl 6; Pitarangsi, Chittima 6; Baqar, Shahida 1; Armstrong, Adam 2; Hshieh, Paul 3; Fox, Anne 2; Maley, Elisabeth A. 4; Lebron, Carlos 5; Faix, Dennis J. 3; Lawler, James V. 2; Nayak, Gautam 2; Lewis, Michael 6; Bodhidatta, Ladaporn 6; Scott, Daniel A. 1
[Article]
Clinical Infectious Diseases.
44(3):338-346, February 1, 2007.
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Background. Traveler's diarrhea in Thailand is frequently caused by Campylobacter jejuni. Rates of fluoroquinolone (FQ) resistance in Campylobacter organisms have exceeded 85% in recent years, and reduced fluoroquinolone efficacy has been observed.
Methods. Azithromycin regimens were evaluated in a randomized, double-blind trial of azithromycin, given as a single 1-g dose or a 3-day regimen (500 mg daily), versus a 3-day regimen of levofloxacin (500 mg daily) in military field clinics in Thailand. Outcomes included clinical end points (time to the last unformed stool [TLUS] and cure rates) and microbiological end points (pathogen eradication).
Results. A total of 156 patients with acute diarrhea were enrolled in the trial. Campylobacter organisms predominated (in 64% of patients), with levofloxacin resistance noted in 50% of Campylobacter organisms and with no azithromycin resistance noted. The cure rate at 72 h after treatment initiation was highest (96%) with single-dose azithromycin, compared with the cure rates of 85% noted with 3-day azithromycin and 71% noted with levofloxacin (P = .002). Single-dose azithromycin was also associated with the shortest median TLUS (35 h; P = .03, by log-rank test). Levofloxacin's efficacy was inferior to azithromycin's efficacy, except in patients with no pathogen identified during the first 24 h of treatment or in patients with levofloxacin-susceptible Campylobacter isolates, in whom it appeared to be equal to azithromycin. The rate of microbiological eradication was significantly better with azithromycin-based regimens (96%-100%), compared with levofloxacin (38%) (P = .001); however, this finding was poorly correlated with clinical outcome. A higher rate of posttreatment nausea in the 30 min after receipt of the first dose (14% vs. <6%; P = .06) was observed as a mild, self-limited complaint associated with single-dose azithromycin.
Conclusions. Single-dose azithromycin is recommended for empirical therapy of traveler's diarrhea acquired in Thailand and is a reasonable first-line option for empirical management in general.
(C) Copyright Oxford University Press 2007.
