Clinical Trial: Efficacy of Rifaximin in Preventing Campylobacteriosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary: 28 healthy volunteers who gave informed consent 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.
Sponsor: Johns Hopkins Bloomberg School of Public Health

Current Primary Outcome: Campylobacteriosis [ Time Frame: 120 hours after challenge ]

A clinical illness meeting at least one of the following patterns:

  • Moderate to severe diarrhea.
  • Fever (present on at least 2 occasions, at least 20 minutes apart) without diarrhea, plus an associated symptom (nausea, vomiting, abdominal cramps, tenesmus, or gross blood in ≥ 2 stools); with consideration of potential alternative diagnosis per clinical investigator based on illness time course and associated symptoms.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Systemic Immune Response [ Time Frame: 1 month ]
    Serum Immunoglobulin A (IgA) and Immunoglobulin G (IgG) response measured by ELISA
  • Mucosal Immune Response [ Time Frame: 1 month ]
    IgA and IgG response measured with specimens of Peripheral Blood Mononuclear Cells (PBMCs).
  • Cell mediated Immune response [ Time Frame: 1 month ]
    Campylobacter antigen specific Interferon gamma (IFN-gamma) response with PBMCs


Original Secondary Outcome:

  • Systemic Immune Response [ Time Frame: 1 month ]
    Serum IgA and IgG response measured by ELISA
  • Mucosal Immune Response [ Time Frame: 1 month ]
    IgA and IgG response measured with specimens of PBMCs.
  • Cell mediated Immune response [ Time Frame: 1 month ]
    Campylobacter antigen specific IFN-gamma response with PBMCs


Information By: Johns Hopkins Bloomberg School of Public Health

Dates:
Date Received: October 29, 2014
Date Started: October 2014
Date Completion:
Last Updated: March 6, 2017
Last Verified: March 2017