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: Completed Phase 4 study, sponsored by Washington University School of Medicine.
NCT03388268 is a Phase 4 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 15 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Stool specimens will be examined via culture and metagenomic analyses for the presence of detectable C. difficile. Presence will be defined as presence of culturable C. difficile in stool any time after collection of enrollment stool samples.
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 |
What the finished NCT03388268 record still lists
NCT03388268 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03388268 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT03388268's enrollment target sits among peer trials
15 1880th of 2000 higher than 100 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01889381 · 15 participants · Phase 2
Human Craniomaxillofacial Allotransplantation
- NCT02530073 · 15 participants · NA
Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH
- NCT02535936 · 15 participants · NA
Cortical Plasticity in Spastic Diplegia After Selective Dorsal Rhizotomy
- NCT02918474 · 15 participants · NA
Decision Making Tool in Supporting Decision Making in Contralateral Prophylactic Mastectomy in Patients With Newly Diagnosed Breast Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI