Given the high operational tempo as well as potential
complication of giving multiple doses of antibiotics along with other chemoprophylactic regimens (eg, doxycycline for malaria), a single high dose daily (QD) regimen was evaluated for TD prevention in a deployment setting. Subjects were military beneficiaries traveling from the United States, with most staying at Incirlik Air Base, Incirlik, Turkey, for 14 days. Subjects were eligible for inclusion in this study if all of the following criteria were met: ≥18 years of age, in good health, and if female, met criteria for non-childbearing potential, or had a negative urine pregnancy test at screening and Rapamycin chemical structure agreed to use a medically approved method of birth control. Exclusion criteria were as follows: antibiotic use within 7 days, antidiarrheal medication within 24, hypersensitivity or allergy to rifaximin or rifampin, acute diarrhea during the 7 days prior to enrollment, or within 24 hours after ingesting initial dose of study drug. Treatments were randomly Selleckchem ZD1839 assigned to consecutive numbers by using an allocation ratio of 1 : 1 in blocks of four for either oral rifaximin 1,100 mg QD (two 550 mg tablets) or matching placebo QD for 14 days. Salix Pharmaceuticals, Inc. (Morrisville, NC,
USA) provided the interventional products in sequentially labeled bottles. Subjects were instructed to take study drug every morning with breakfast, and missed doses were to be taken with the following meal. TD was defined as the coexistence of acute diarrhea (≥3 unformed stools within a 24-h period) and one or more of the following signs or symptoms of enteric infection: abdominal pain or cramps, moderate to severe increase in intestinal gas, nausea, filipin vomiting, fever (≥37.8°C), fecal urgency, tenesmus, or gross blood and/or mucus in the stool. Stools were defined
as formed (retained shape), soft (assumed shape of container and could not be poured, but would not hold form if placed on a surface; often had a custard or pudding-like consistency), or watery (could be poured). Additionally, subjects who had diarrhea and took a medication specifically for relief from the symptoms of diarrhea were categorized as having TD. Enteric symptoms were assessed via daily subject diary entries and weekly clinic visits. Adherence was assessed during weekly follow-up visits through pill counts and interview. In addition, safety was assessed by monitoring adverse events. Excluding preestablished weekly visits, subjects could go to the clinic at any time of the day throughout the study on an informal basis. Stool specimens were collected for the purpose of conducting etiological agent analyses; however, only five acute specimens were submitted, and, therefore, results of these analyses will not be reported herein.
No related posts.