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- Title
Trial Evaluating Ambulatory Therapy of Travelers' Diarrhea (TrEAT TD) Study: A Randomized Controlled Trial Comparing 3 Single-Dose Antibiotic Regimens With Loperamide.
- Authors
Riddle, Mark S.; Connor, Patrick; Fraser, Jamie; Porter, Chad K.; Swierczewski, Brett; Hutley, Emma J.; Danboise, Brook; Simons, Mark P.; Hulseberg, Christine; Lalani, Tahaniyat; Gutierrez, Ramiro L.; Tribble, David R.
- Abstract
Background. Recommended treatment for travelers' diarrhea includes the combination of an antibiotic, usually a fluoroquinolone or azithromycin, and loperamide for rapid resolution of symptoms. However, adverse events, postdose nausea with high-dose azithromycin, effectiveness of single-dose rifaximin, and emerging resistance to front-line agents are evidence gaps underlying current recommendations. Methods. A randomized, double-blind trial was conducted in 4 countries (Afghanistan, Djibouti, Kenya, and Honduras) between September 2012 and July 2015. US and UK service members with acute watery diarrhea were randomized and received single-dose azithromycin (500 mg; 106 persons), levofloxacin (500 mg; 111 persons), or rifaximin (1650 mg; 107 persons), in combination with loperamide (labeled dosing). The efficacy outcomes included clinical cure at 24 hours and time to last unformed stool. Results. Clinical cure at 24 hours occurred in 81.4%, 78.3%, and 74.8% of the levofloxacin, azithromycin, and rifaximin arms, respectively. Compared with levofloxacin, azithromycin was not inferior (P = .01). Noninferiority could not be shown with rifaximin (P = .07). At 48 and 72 hours, efficacy among regimens was equivalent (approximately 91% at 48 and 96% at 72 hours). The median time to last unformed stool did not differ between treatment arms (azithromycin, 3.8 hours; levofloxacin, 6.4 hours; rifaximin, 5.6 hours). Treatment failures were uncommon (3.8%, 4.4%, and 1.9% in azithromycin, levofloxacin, and rifaximin arms, respectively) (P = .55). There were no differences between treatment arms with postdose nausea, vomiting, or other adverse events. Conclusions. Single-dose azithromycin, levofloxacin, and rifaximin with loperamide were comparable for treatment of acute watery diarrhea.
- Subjects
DIARRHEA prevention; ANTIDIARRHEALS; ANTIBIOTICS; QUINOLONE antibacterial agents; MILITARY personnel; TRAVEL hygiene; AZITHROMYCIN; RANDOMIZED controlled trials; TREATMENT effectiveness; BLIND experiment
- Publication
Clinical Infectious Diseases, 2017, Vol 65, Issue 12, p2008
- ISSN
1058-4838
- Publication type
Article
- DOI
10.1093/cid/cix693