NCT02280044

Efficacy of Rifaximin in Preventing Campylobacteriosis

Double Blind, Placebo-Controlled Trial Assessing the Efficacy of Rifaximin in Preventing Campylobacteriosis in Subjects Challenged With Campylobacter Jejuni

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Johns Hopkins Bloomberg School of Public Health · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study is a randomized, double-blinded, placebo-controlled, in-patient trial evaluating the prophylactic efficacy of rifaximin against campylobacteriosis following challenge with C. jejuni.

Detailed description

30 healthy volunteers (2 of these were planned alternates) gave informed consent and were enrolled to participate in a study to determine the efficacy of prophylactic rifaximin in preventing diarrheal illness following challenge with C. jejuni, strain CG8421. Volunteers were screened for inclusion and exclusion criteria and were admitted to the inpatient unit of the Center for Immunization Research at Johns Hopkins University. Volunteers were treated with rifaximin or placebo in a double blind manner for four days, beginning the day prior to challenge. On the day of challenge, the volunteers were given 5x10(5) C. jejuni with bicarbonate buffer and were then monitored and treated for any symptoms. Stools were cultured daily for the excretion of C. jejuni and all subjects were treated with antibiotics to insure that the challenge strain has cleared prior to to discharge. Subjects were followed for six months following the inpatient phase to detect adverse events following the study.

Conditions

• Dysentery
• Diarrhea
• Enteric Campylobacteriosis

Interventions

Type	Name	Description
BIOLOGICAL	Rifaximin intervention	Rifaximin administered then Challenge with C jejuni
BIOLOGICAL	Placebo intervention	Placebo administered then Challenge with C jejuni

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-08-09
• Completion: 2016-08-09
• First posted: 2014-10-31
• Last updated: 2018-11-20
• Results posted: 2018-11-20

Locations

1 site across 1 country: United States