Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a NA study that was terminated before completion, run by Corewell Health East. The registered enrollment target is 2 participants.
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.
Interventions
- DRUG Vancomycin
- DRUG Saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2011-04 |
| Est. Completion | 2012-02 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01346059
The ClinicalTrials.gov registry entry for NCT01346059 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Corewell Health East, which has 106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Vancomycin is the first listed.
NCT01346059 reports 0 study locations.
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
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.