Status:
COMPLETED
TOX NEG Trial: Clostridium Difficile Diagnosis and Treatment
Lead Sponsor:
Washington University School of Medicine
Conditions:
Clostridium Difficile Infection
Diarrhea
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine the risks and benefits of antibiotic treatment for Clostridium difficile infection (CDI) among patients whose stool samples are nucleic acid amplification tes...
Detailed Description
Study Purpose: The purpose of this study is to determine the risks and benefits of antibiotic treatment for Clostridium difficile infection (CDI) among patients whose stool samples are nucleic acid a...
Eligibility Criteria
Inclusion
- Stool submitted to the BJH microbiology laboratory for C. difficile testing that tests negative for C. difficile toxins (C. difficile Tox A/B II, Alere, Waltham, MA) as part of routine clinical care and positive by NAAT (Xpert C. difficile, Cepheid, Sunnyvale, CA)
- Clinically significant diarrhea (≥3 diarrheal bowel movements per day or ≥1 diarrheal bowel movement plus abdominal pain)
- ≥18 years of age.
Exclusion
- The presence of a condition associated with persistent / prolonged / recurrent diarrhea, including, but not limited to:
- Upcoming chemotherapy
- Previous or upcoming bone marrow/hematopoietic stem cell transplant,
- Leukemia: new, not in remission, or receiving chemotherapy
- Inflammatory bowel disease
- Crohn's disease
- Ulcerative colitis
- Microscopic colitis
- Previous total colectomy
- Previous partial colectomy without return to formed bowel movement or previous resection of colon
- Colostomy or ileostomy
- Unable to follow study procedures
- Not expected to survive until study follow-up is complete
- Allergy or intolerance to oral vancomycin
- A history of CDI in the past 3 months
- Alternate infectious etiology for diarrhea
- Receipt of CDI antibiotic treatment (excluding empiric treatment given while pending EIA results)
- Does not provide consent will exclude a patient from participating in the trial.
Key Trial Info
Start Date :
December 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03388268
Start Date
December 29 2017
End Date
January 31 2021
Last Update
July 26 2021
Active Locations (1)
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1
Washington University
St Louis, Missouri, United States, 63110