Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03880539 · ClinicalTrials.gov registry record · Phase 4
Bezlotoxumab (BEZLO) In Addition To Standard Of Care (SOC) Vancomycin For The Treatment of Multi-Recurrent Clostridium Difficile Infection
A Phase 4 study, sponsored by University of Kansas Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 4
- Enrollment target
NCT03880539: Completed Phase 4 study, sponsored by University of Kansas Medical Center.
NCT03880539 is a Phase 4 study that has completed, run by University of Kansas Medical Center. The registered enrollment target is 4 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03880539, a Phase 4 study, has completed, sponsored by University of Kansas Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 4 participants
- Enrollment target
Study Summary
This is a research study to collect information from people that have Clostridium difficile infection (CDI) and are treated with a standard antibiotic treatment in which the antibiotic dose is gradually reduced over 6 weeks and bezlotoxumab (BEZLO), an approved monoclonal antibody targeting C. difficile toxin, which has shown to reduce CID recurrence when used in combination with standard antibiotic treatment.
Primary Outcome
If diarrhea resolves (defined as \<2 loose stools per day for at least 2 consecutive days) and subsequently begins again (3 or more loose stools in 24 hours or less for at least 2 consecutive days), this will represent a new episode of diarrhea. If there is a new episode of diarrhea at any time during the 12-week study period, an unscheduled visit will be conducted. A stool sample will be provided for any new episode of diarrhea which occurs and a stool test for toxigenic C. difficile (NAAT plus
Interventions
- DRUG bezlotoxumab
- DRUG Vancomycin Oral
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2019-06-25 |
| Est. Completion | 2021-11-18 |
| Phase | Phase 4 |
What the finished NCT03880539 record still lists
NCT03880539 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which bezlotoxumab is the first listed.
NCT03880539 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03880539 about?
NCT03880539 is a clinical study titled "Bezlotoxumab (BEZLO) In Addition To Standard Of Care (SOC) Vancomycin For The Treatment of Multi-Recurrent Clostridium Difficile Infection". This is a research study to collect information from people that have Clostridium difficile infection (CDI) and are treated with a standard antibiotic treatment in which the antibiotic dose is gradually reduced over 6 weeks and bezlotoxumab (BEZLO), an approved monoclonal antibody targeting C. diffi...
What is the current status of trial NCT03880539?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 4 participants. The study started on 2019-06-25. Estimated completion is 2021-11-18.
What interventions are being tested in trial NCT03880539?
The interventions under investigation include: bezlotoxumab (DRUG), Vancomycin Oral (DRUG).
Who is sponsoring clinical trial NCT03880539?
This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03880539's enrollment target sits among peer trials
4 1994th of 2000 higher than 6 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 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