TOX NEG Trial: Clostridium Difficile Diagnosis and Treatment
Condition: Clostridium Difficile Infection; Diarrhea
MeSH terms: Clostridium Infections; Diarrhea
Intervention: Oral Vancomycin; Placebo; Toxin enzyme immunoassay; Nuceleic acid amplification test
Intervention description: Oral vancomycin 125mg 4 times per day; Sugar liquid manufactured to mimic oral vancomycin 125mg; EIA assay: Wampole/Tech Lab Tox A/B II; NAAT: Xpert C. difficile, Cepheid
Intervention MeSH terms: Vancomycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blinded randomized controlled trial of CDI treatment with oral vancomycin vs. placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Placebo
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Clostridium difficile; Diarrhea

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 test (NAAT) positive and enzyme immunoassay (EIA) negative for C. difficile.

      Currently, healthcare facilities use a wide variety of tests and strategies for identifying
      patients with CDI; both EIA and NAAT are widely used. There is no clear gold standard for
      identifying CDI. At WUSM and BJH, patients are only treated for CDI if they have a positive
      EIA. However, at many other healthcare facilities, the standard of care is to treat for CDI
      if the patient is NAAT positive. Some patients who are NAAT-positive may not have true CDI;
      while this treatment is standard of care at many facilities, the risk and benefits of
      treating these patients for CDI is unknown.

      We propose to perform a double blinded, randomized controlled non-inferiority trial of
      antimicrobial of patients who are EIA negative, NAAT positive to determine the risks and
      benefits of CDI treatment in this population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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.