Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03388268 · ClinicalTrials.gov registry record · Phase 4
TOX NEG Trial: Clostridium Difficile Diagnosis and Treatment
A Phase 4 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 4
- Development phase
- 15
- Enrollment target
NCT03388268 is a Phase 4 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 15 participants.
The verdict
NCT03388268, a Phase 4 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 15 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Oral Vancomycin
- DEVICE Toxin enzyme immunoassay
- DEVICE Nuceleic acid amplification test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2017-12-29 |
| Est. Completion | 2021-01-31 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03388268
The ClinicalTrials.gov registry entry for NCT03388268 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03388268 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03388268 about?
NCT03388268 is a clinical study titled "TOX NEG Trial: Clostridium Difficile Diagnosis and Treatment". 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 fac...
What is the current status of trial NCT03388268?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 15 participants. The study started on 2017-12-29. Estimated completion is 2021-01-31.
What interventions are being tested in trial NCT03388268?
The interventions under investigation include: Placebo (DRUG), Oral Vancomycin (DRUG), Toxin enzyme immunoassay (DEVICE), Nuceleic acid amplification test (DEVICE).
Who is sponsoring clinical trial NCT03388268?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.