We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

TOX NEG Trial: Clostridium Difficile Diagnosis and Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03388268
Recruitment Status : Enrolling by invitation
First Posted : January 1, 2018
Last Update Posted : January 1, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
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 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.


Condition or disease Intervention/treatment Phase
Clostridium Difficile Infection Diarrhea Drug: Oral Vancomycin Drug: Placebo Device: Toxin enzyme immunoassay Device: Nuceleic acid amplification test Phase 4

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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
Primary Purpose: Other
Official Title: Double Blinded, Randomized Controlled Trial of Oral Vancomycin Versus Placebo in Hospitalized Patients With Diarrhea and Stool toXin NEGative But Nucleic Acid Amplification Test Positive for Toxigenic Clostridium Difficile (TOX NEG Trial)
Anticipated Study Start Date : December 2017
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Oral vancomycin
125mg of oral vancomycin four times per day
Drug: Oral Vancomycin
Oral vancomycin 125mg 4 times per day
Other Name: Vancocin
Device: Toxin enzyme immunoassay
EIA assay: Wampole/Tech Lab Tox A/B II
Device: Nuceleic acid amplification test
NAAT: Xpert C. difficile, Cepheid
Placebo Comparator: Placebo
Placebo four times per day
Drug: Placebo
Sugar liquid manufactured to mimic oral vancomycin 125mg
Device: Toxin enzyme immunoassay
EIA assay: Wampole/Tech Lab Tox A/B II
Device: Nuceleic acid amplification test
NAAT: Xpert C. difficile, Cepheid


Outcome Measures

Primary Outcome Measures :
  1. Acquisition of C. difficile [ Time Frame: Through 8 weeks after completion of study drug ]
    Stool specimens will be examined via culture and metagenomic analyses for the presence of detectable C. difficile. Acquisition will be defined as presence of C. difficile or other multidrug resistant organism in stool that was not present at baseline.

  2. Persistence of C. difficile [ Time Frame: Through 8 weeks after completion of study drug ]
    Stool specimens will be examined via culture and metagenomic analyses for the presence of detectable C. difficile. Persistence will be defined as presence of C. difficile or other multidrug resistant organism in stool at baseline and post-intervention.


Secondary Outcome Measures :
  1. Environmental contamination [ Time Frame: Through 8 weeks after completion of study drug ]
    Swabs from participants' home and hospital environments will be examined via culture and metagenomic analyses for the presence and/or persistence of C. difficile and other multidrug resistant organisms.

  2. Duration of diarrhea as defined by daily symptoms and questionnaire using the Bristol Stool Chart [ Time Frame: Through 8 weeks after completion of study drug ]
    Duration of diarrhea will be compared between groups. Duration of diarrhea will be assessed daily during study drug using a questionnaire and the Bristol Stool Chart. The Bristol Stool Chart measures stool consistency. Diarrhea will be defined as Bristol Stool Chart types 5-7.

  3. Severity of diarrhea as defined by daily symptoms and questionnaire using the Bristol Stool Chart [ Time Frame: Through 8 weeks after completion of the study drug ]
    Severity of diarrhea will be compared between groups. Severity of diarrhea will be assessed daily during study drug using a questionnaire and the Bristol Stool Chart. The Bristol Stool Chart measures stool consistency. Diarrhea will be defined as Bristol Stool Chart types 5-7.

  4. Presence of other multidrug resistant organisms [ Time Frame: Through 8 weeks after completion of the study drug ]
    Stool specimens will be examined via culture and metagenomic analyses for the presence of multidrug resistant organisms before and after study drug.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

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): NCT03388268


Locations
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Erik Dubberke, MD, MSPH Washington University School of Medicine
More Information

Responsible Party: Erik Dubberke, Associate Professor of Medicine, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03388268     History of Changes
Other Study ID Numbers: 201708055
First Posted: January 1, 2018    Key Record Dates
Last Update Posted: January 1, 2018
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Erik Dubberke, Washington University School of Medicine:
Clostridium difficile
Diarrhea

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents