Status:
COMPLETED
Efficacy of Rifaximin in Preventing Campylobacteriosis
Lead Sponsor:
Johns Hopkins Bloomberg School of Public Health
Collaborating Sponsors:
Naval Medical Research Center
Uniformed Services University of the Health Sciences
Conditions:
Dysentery
Diarrhea
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
PHASE3
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 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...
Eligibility Criteria
Inclusion
- 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:
- Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal. For purposes of this study, postmenopausal is defined as one year without menses); or must have documentation of having undergone tubal ligation or hysterectomy. OR
- Childbearing potential; has a negative serum pregnancy test at screening and a negative urine pregnancy test on admission (Study Day -1), and agrees to the use of an efficacious hormonal or barrier method of birth control during the study, abstinence is acceptable
Exclusion
- General health/issues
- 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
- Positive urine toxicology screen
- 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
- Study-specific exclusionary conditions based on potential increased risk or complicating outcome ascertainment. (See protocol details for complete list of exclusions.)
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 9 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02280044
Start Date
October 1 2014
End Date
August 9 2016
Last Update
November 20 2018
Active Locations (1)
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1
Center for Immunization Research, Johns Hopkins Bloomberg School of Public Heatlh
Baltimore, Maryland, United States, 21205