Traveler’s Diarrhea in Thailand: Randomized, Double‐Blind Trial Comparing Single‐Dose and 3‐Day Azithromycin‐Based Regimens with a 3‐Day Levofloxacin Regimen
1Enteric Diseases Department, Naval Medical Research Center, Silver Spring, 2National Naval Medical Center, and 3Uniformed Services University, Bethesda, Maryland; 4Naval Medical Center, San Diego, San Diego, California; 5Navy Environmental Preventive Medicine Unit 6, Pearl Harbor, Hawaii; and 6Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand
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 (
). Single‐dose azithromycin was also associated with the shortest median TLUS (35 h; 
, 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%) (
); 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%; 
) 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.
Received 12 June 2006; accepted 19 September 2006; electronically published 28 December 2006.
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(See the editorial commentary by DuPont on pages 347–9)
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Presented in part: 8th Conference of the International Society of Travel Medicine, 7–11 May 2003, New York City, New York (abstract FC10.02).
The views expressed in this article are those of the authors and do not necessarily reflect the official policy or position of the Department of Navy, Department of Defense, or the US Government. The corresponding author is an employee of the US Government. This work was prepared as part of my official duties. Title 17 US Code 101 defines a US Government work as a work prepared by a military service member or employee of the US Government as part of that person’s official duties.