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NCT01346059 · ClinicalTrials.gov registry record · NA
Intracolonic Vancomycin Therapy in Severe C. Diff Colitis
A NA study, sponsored by Corewell Health East.
- Terminated
- Registry status
- NA
- Development phase
- 2
- Enrollment target
NCT01346059: Clinical Trial NA study, sponsored by Corewell Health East.
NCT01346059 is a NA study that was terminated before completion, run by Corewell Health East. The registered enrollment target is 2 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01346059, a NA study, was terminated before completion, sponsored by Corewell Health East.
- TERMINATED
- Registry status
- NA
- Development phase
- 2 participants
- Enrollment target
Study Summary
Clostridium difficile is a bacteria that can infect the colon and cause severe diarrhea in patients after recent antibiotic use. The current standard of care treatment for severe C. diff. consists of oral vancomycin and/or intravenous metronidazole. When treatment is unsuccessful, it can lead to need for removal of the entire colon or even death. In fact, mortality rates in the literature range from 11-37% for C. diff. The most commonly quoted mortality rate is 14% for severe infection. It is believed that the failure of treatment may stem from an adynamic ileus (paralysis of the small bowel). This ileus may prevent the oral vancomycin from reaching the colon and therefore it does not treat the problem. Vancomycin functions by direct contact with the colon. Therefore, if the vancomycin is instilled directly into the colon, it can come into contact with and be its intended target. : The objective of the study is to improve treatment of severe C. diff. colitis . C. diff. infection is defined as severe if there is evidence of ileus accompanied by any one of the following: fever greater than 38.30C, , acidemia, serum albumin less than 2.5, or white blood cell count greater than 14,000.
Primary Outcome
If the patient has resolution of diarrhea, white blood cell count, and abdominal pain, the protocol will be stopped.
Interventions
- DRUG Vancomycin
- DRUG Saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2011-04 |
| Est. Completion | 2012-02 |
| Phase | NA |
Why NCT01346059 stopped before completion
NCT01346059 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Vancomycin is the first listed.
NCT01346059 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01346059 about?
NCT01346059 is a clinical study titled "Intracolonic Vancomycin Therapy in Severe C. Diff Colitis". Clostridium difficile is a bacteria that can infect the colon and cause severe diarrhea in patients after recent antibiotic use. The current standard of care treatment for severe C. diff. consists of oral vancomycin and/or intravenous metronidazole. When treatment is unsuccessful, it can lead to nee...
What is the current status of trial NCT01346059?
This trial is currently terminated. It is a NA study. The enrollment target is 2 participants. The study started on 2011-04. Estimated completion is 2012-02.
What interventions are being tested in trial NCT01346059?
The interventions under investigation include: Vancomycin (DRUG), Saline (DRUG).
Who is sponsoring clinical trial NCT01346059?
This trial is sponsored by Corewell Health East, which has 106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01346059's enrollment target sits among peer trials
2 1997th of 2000 the lowest of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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
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