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Efficacy of Rifaximin in Preventing Campylobacteriosis

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ClinicalTrials.gov Identifier: NCT02280044
Recruitment Status : Completed
First Posted : October 31, 2014
Results First Posted : November 20, 2018
Last Update Posted : November 20, 2018
Sponsor:
Collaborators:
Naval Medical Research Center
Uniformed Services University of the Health Sciences
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dysentery Diarrhea Enteric Campylobacteriosis Biological: Rifaximin intervention Biological: Placebo intervention Phase 2 Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Double Blind, Placebo-Controlled Trial Assessing the Efficacy of Rifaximin in Preventing Campylobacteriosis in Subjects Challenged With Campylobacter Jejuni
Study Start Date : October 2014
Actual Primary Completion Date : August 9, 2016
Actual Study Completion Date : August 9, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Rifaximin

Arms and Interventions
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Arm Intervention/treatment
Experimental: rifaximin
Subjects receiving rifaximin prophylaxis will be challenged with C. jejuni
 Biological: Rifaximin intervention
Rifaximin administered then Challenge with C jejuni
Placebo Comparator: placebo
Subjects receiving placebo will be challenged with C. jejuni
 Biological: Placebo intervention
Placebo administered then Challenge with C jejuni


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female between 18 and 50 years of age, inclusive
  2. 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)
  3. Demonstrate comprehension of the protocol procedures and knowledge of Campylobacter illness by passing a written examination (pass grade ≥ 70%)
  4. Willing to participate after informed consent obtained
  5. 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

  6. 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 Criteria:

General health/issues

  1. 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
  2. Evidence of Immunoglobulin A deficiency (serum IgA < 7 mg/dL or below the limit of detection of assay)
  3. Positive serology results for HIV, HBsAg, or Hepatitis C virus antibodies
  4. Positive urine toxicology screen
  5. Significant abnormalities in screening laboratory hematology or serum chemistry, as determined by PI or PI in consultation with the Research Monitor and sponsor
  6. 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
  7. 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.)

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02280044


Locations
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United States, Maryland
Center for Immunization Research, Johns Hopkins Bloomberg School of Public Heatlh
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Naval Medical Research Center
Uniformed Services University of the Health Sciences
Investigators
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Principal Investigator: Kawsar Talaat, M.D. Johns Hopkins Bloomberg School of Public Health
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT02280044    
Other Study ID Numbers: CIR296
First Posted: October 31, 2014    Key Record Dates
Results First Posted: November 20, 2018
Last Update Posted: November 20, 2018
Last Verified: October 2018
Keywords provided by Johns Hopkins Bloomberg School of Public Health:
Campylobacter jejuni
rifaximin
antibiotic prophylaxis
dysentery
diarrhea
Additional relevant MeSH terms:
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Campylobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Dysentery
Diarrhea
Signs and Symptoms, Digestive
 Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Rifaximin
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents