ColitisNCT01346059
Intracolonic Vancomycin Therapy in Severe C. Diff Colitis
A study testing Vancomycin and Saline in people with Colitis, run by Corewell Health East at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colitis
- What is being tested?
- Vancomycin and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Feb 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SICU patient
- positive c. diff toxin assay
- visualization of pseudomembranes on colonoscopy,
- able to give consent or have representative to give consent.
Who cannot join
- Under age 18
- pregnant
- absence of a colon or surgical discontinuity of bowel
- allergy to vancomycin
- need for anti-diarrheal medication
- need for prolonged antibiotics for other cause
Show all 11Show fewer
- need for probiotics
- need for other medications with action against C. diff.
- need for surgery, colon perforation
- recent IV IG use
- toxic megacolon.
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
Official title: Intracolonic Vancomycin Therapy in Severe C. Diff Colitis: A Double Blinded Randomized Prospective Trial
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.
Read the detailed description
Patients in the surgical intensive care unit with severe C. diff. are eligible and if consented will be randomized in a 1:1 ratio to a control group or the treatment group. Each group will undergo a colonoscopy on day one of the study. A 14 French Cook colonic decompression catheter will be placed at that time. This catheter is a 175cm long soft flexible catheter designed to be placed in the colon. Its usual use is to remove air from a colon that is dilated. The catheter is placed into the colon by first placing a guidewire through the colonoscope. The colonoscope is then removed leaving the guidewire in place. The catheter is then thread into the colon over the guidewire. An xray is obtained to confirm the location of the catheter and then the guidewire is removed. The guidewire is a very thin, soft, flexible wire. The patient will not have any undue discomfort secondary to the catheter. The control group will have 250cc of sterile saline solution instilled through the catheter into the colon every 6 hours. The study group will have 250cc of vancomycin solution instilled every 6 hours. The solution will be 2 grams vancomycin dissolved in a 1 liter normal saline irrigation bottle. The catheter will be clamped in both groups after instillation until the next treatment. Of note, both groups will receive the current standard treatment of 500mg IV metronidazole every 8 hours and 250mg oral vancomycin every 6 hours throughout the study. Every day the patients will have a blood draw to check the white blood cell count as is the current practice. The patients will also have a vancomycin trough level checked via blood test. This will occur just prior to the first dosing on treatment day number 3. This will be a blinded lab value as to not unblind the investigators. At resolution Patients will undergo a repeat colonoscopy when there is a decrease of diarrhea (less than 3 stools daily) and a normalized white blood cell count or on day 7 if symptoms persist. The expected length of treatment is approximately 7 days. If there is no improvement at fourteen days, the trial will be stopped for futility. The trial will also be halted if the attending physician determines that the patient needs surgery or if the clinical status of the patient has deteriorated to a point where keeping the patient enrolled will potentially cause harm. Follow-up after completing the trial will consist of phone interviews to screen for recurrence of infection. A weekly phone call will be made for the first three weeks and then two monthly calls will take place after that for a total of three months follow-up. The primary investigator will make these phone calls.
- Conditions
- Colitis
- Being tested
- Vancomycin, Saline
- Keywords
- Clostridium, Colitis, Intracolonic vancomycin, psuedomembranous colitis
- Medical subject headings
- Colitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VancomycinDrug
Also called Vancocin
Vancomycin solution will be instilled through the colonic catheter every 6 hours. 250cc of solution will be used each time. The solution is 2 grams vancomycin mixed in 1 liter normal saline.
SalineDrug
Also called Normal Saline
Saline, used as a placebo, will be instilled through the colonic catheter. Every 6 hours, 250cc of saline will be used.
| Study group | Role | What they receive |
|---|---|---|
| Saline | Placebo comparator | The saline arm will receive normal saline through the catheter as a placebo. Receives: Drug: Saline |
| Vancomycin | Experimental | The vancomycin arm will receive vancomycin solution through the catheter. Receives: Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of Diarrhea and White Blood Cell Count Elevation
If the patient has resolution of diarrhea, white blood cell count, and abdominal pain, the protocol will be stopped.
Measured: 14 days
Secondary outcomes (2)
Mortality
Death within 30 days of enrollment, in or out of hospital
Measured: 30 day
Need for Colectomy
Partial or complete colectomy performed within 30 days of enrollment
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2011 (estimated)
- Study startApr 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Why it stopped: Technical issues with catheter placement; researcher left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc B Grodsky, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346059
- Sponsor's protocol ID
- 2010-195
- Status last verified
- Dec 2016
- First submitted
- 3 Mar 2011
- Last updated
- 29 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracolonic Vancomycin Therapy in Severe C. Diff Colitis: A Double Blinded Randomized Prospective Trial
- ClinicalTrials.gov ID
- NCT01346059
- Acronym / sponsor ID
- 2010-195
- Conditions
- Colitis
- Keywords
- Clostridium, Colitis, Intracolonic vancomycin, psuedomembranous colitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Technical issues with catheter placement; researcher left institution
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 2 May 2011 (estimated)
- Results
- Posted 29 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients in the surgical intensive care unit with severe C. diff. are eligible and if consented will be randomized in a 1:1 ratio to a control group or the treatment group. Each group will undergo a colonoscopy on day one of the study. A 14 French Cook colonic decompression catheter will be placed at that time. This catheter is a 175cm long soft flexible catheter designed to be placed in the colon. Its usual use is to remove air from a colon that is dilated. The catheter is placed into the colon by first placing a guidewire through the colonoscope. The colonoscope is then removed leaving the guidewire in place. The catheter is then thread into the colon over the guidewire. An xray is obtained to confirm the location of the catheter and then the guidewire is removed. The guidewire is a very thin, soft, flexible wire. The patient will not have any undue discomfort secondary to the catheter. The control group will have 250cc of sterile saline solution instilled through the catheter into the colon every 6 hours. The study group will have 250cc of vancomycin solution instilled every 6 hours. The solution will be 2 grams vancomycin dissolved in a 1 liter normal saline irrigation bottle. The catheter will be clamped in both groups after instillation until the next treatment. Of note, both groups will receive the current standard treatment of 500mg IV metronidazole every 8 hours and 250mg oral vancomycin every 6 hours throughout the study. Every day the patients will have a blood draw to check the white blood cell count as is the current practice. The patients will also have a vancomycin trough level checked via blood test. This will occur just prior to the first dosing on treatment day number 3. This will be a blinded lab value as to not unblind the investigators. At resolution Patients will undergo a repeat colonoscopy when there is a decrease of diarrhea (less than 3 stools daily) and a normalized white blood cell count or on day 7 if symptoms persist. The expected length of treatment is approximately 7 days. If there is no improvement at fourteen days, the trial will be stopped for futility. The trial will also be halted if the attending physician determines that the patient needs surgery or if the clinical status of the patient has deteriorated to a point where keeping the patient enrolled will potentially cause harm. Follow-up after completing the trial will consist of phone interviews to screen for recurrence of infection. A weekly phone call will be made for the first three weeks and then two monthly calls will take place after that for a total of three months follow-up. The primary investigator will make these phone calls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline | Placebo comparator | Drug: SalineThe saline arm will receive normal saline through the catheter as a placebo. |
| Vancomycin | Experimental | Drug: VancomycinThe vancomycin arm will receive vancomycin solution through the catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- SICU patient
- positive c. diff toxin assay
- visualization of pseudomembranes on colonoscopy,
- able to give consent or have representative to give consent.
Key exclusion criteria (11 listed)
- Under age 18
- pregnant
- absence of a colon or surgical discontinuity of bowel
- allergy to vancomycin
- need for anti-diarrheal medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VancomycinAlso: VancocinVancomycin solution will be instilled through the colonic catheter every 6 hours. 250cc of solution will be used each time. The solution is 2 grams vancomycin mixed in 1 liter normal saline. | Drug | Vancomycin |
| SalineAlso: Normal SalineSaline, used as a placebo, will be instilled through the colonic catheter. Every 6 hours, 250cc of saline will be used. | Drug | Saline |
Primary outcome
Resolution of Diarrhea and White Blood Cell Count Elevation
Time frame: 14 days
If the patient has resolution of diarrhea, white blood cell count, and abdominal pain, the protocol will be stopped.
2 secondary outcomes
Mortality
Time frame: 30 day
Need for Colectomy
Time frame: 30 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc B Grodsky, MD principal investigator
Corewell Health East
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vancomycin and Saline in people with Colitis, run by Corewell Health East at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of Diarrhea and White Blood Cell Count Elevation (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.