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Clin Infect Dis. 2017 Nov 29;65(12):2008-2017. doi: 10.1093/cid/cix693.

Trial Evaluating Ambulatory Therapy of Travelers' Diarrhea (TrEAT TD) Study: A Randomized Controlled Trial Comparing 3 Single-Dose Antibiotic Regimens With Loperamide.

Author information

1
Naval Medical Research Center, Silver Spring, Maryland.
2
Academic Department of Military Medicine, Royal Centre for Defence Medicine, Birmingham, United Kingdom.
3
Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences, Bethesda, Maryland.
4
Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Bethesda, Maryland.
5
Armed Forces Research Institute for the Medical Sciences, Bangkok, Thailand.
6
Centre of Defence Pathology, Royal Centre for Defence Medicine, Birmingham, United Kingdom.
7
US Army Research Unit Kenya, Kericho.
8
Naval Medical Research Unit No. 6, Lima, Peru.
9
Naval Medical Center, Portsmouth, Virginia.

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.

Clinical Trial Registration:

NCT01618591.

KEYWORDS:

azithromycin; levofloxacin; randomized control trial; rifaximin; travelers’ diarrhea

PMID:
29029033
PMCID:
PMC5848251
[Available on 2018-11-29]
DOI:
10.1093/cid/cix693
[Indexed for MEDLINE]

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