Efficacy of Rifaximin in Preventing Campylobacteriosis (NCT02280044) | Clinical Trial Compass
CompletedPhase 2/3
Efficacy of Rifaximin in Preventing Campylobacteriosis
United States30 participantsStarted 2014-10
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. Male or female between 18 and 50 years of age, inclusive
✓. General good health, without significant medical illness, abnormal physical examination findings or clinically significant laboratory abnormalities, as determined by the PI (may consult with the Research Monitor on a case-by-case basis)
✓. Demonstrate comprehension of the protocol procedures and knowledge of Campylobacter illness by passing a written examination (pass grade ≥ 70%)
✓. Willing to participate after informed consent obtained
✓. Available for all planned follow-up visits and remain available for clinic visits (for examination, blood draws and stool collection) and monitoring for 90 days post-challenge and by phone for 180 days post-challenge
✓. If the subject is female, she is eligible to enter if she is of:
Exclusion criteria
✕. Presence of a significant medical condition (e.g., psychiatric conditions; gastrointestinal disease, such as peptic ulcer,symptoms or evidence of active gastritis/dyspepsia, inflammatory bowel disease, irritable bowel syndrome (as defined by the Rome III criteria or medical diagnosis); alcohol or illicit drug abuse/dependency) or laboratory abnormalities which in the opinion of the investigator preclude participation in the study
✕. Evidence of Immunoglobulin A deficiency (serum IgA \< 7 mg/dL or below the limit of detection of assay)
✕. Positive serology results for HIV, HBsAg, or Hepatitis C virus antibodies
What they're measuring
1
Campylobacteriosis
Timeframe: 120 hours after challenge
Trial details
NCT IDNCT02280044
SponsorJohns Hopkins Bloomberg School of Public Health
✕. Significant abnormalities in screening laboratory hematology or serum chemistry, as determined by PI or PI in consultation with the Research Monitor and sponsor
✕. Use of any medication known to affect the immune function (e.g., corticosteroids and others) within 30 days preceding receipt of the challenge inoculum or planned to be used during the active study period
✕. Nursing mother on the day of admittance to the inpatient unit