Clostridium Difficile ColitisNCT00861887
Extended Treatment With Vancomycin for Clostridium Difficile Colitis
A study testing Standard Vancomycin and Extended Vancomycin in people with Clostridium Difficile Colitis, run by Corewell Health East at 1 site in United States.
Trial summary
BACKGROUND: Clostridium difficile-associated colitis is an infection of the large bowel, usually associated with previous use of antibiotics. The disease course may be complicated by fulminant disease requiring removal of the colon or by multiple recurrences requiring re-hospitalization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile Colitis
- What is being tested?
- Standard Vancomycin and Extended Vancomycin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jan 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- First episode of Clostridium difficile colitis, defined by a positive toxin assay plus at least one of the following: diarrhea, toxic megacolon or leukocytosis.
Who cannot join
- previous diagnosis of Clostridium difficile colitis
- concomitant use of oral Metronidazole, Rifampin, Rifaximin, Nitazoxanide, Sacharromyce boulardii or Lactobacillus spp.
- age less than 18 years-old
- pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
Official title: Comparative Study of 2 Weeks Versus 4 Weeks Treatment With Vancomycin for Clostridium Difficile Colitis
BACKGROUND: Clostridium difficile-associated colitis is an infection of the large bowel, usually associated with previous use of antibiotics. The disease course may be complicated by fulminant disease requiring removal of the colon or by multiple recurrences requiring re-hospitalization. The incidence and severity of Clostridium difficile infection is rising, and it poses an increasing burden on the health system. For example, in one of our previous studies we found that 804 in-patients and 568 out-patients had a positive test for Clostridium difficile toxin at Beaumont Laboratories in 2003. The standard treatment is a 2 week course of Vancomycin or Metronidazole. The clinical response to Metronidazole appears to be declining, and many practicing clinicians prefer Vancomycin as a first-line treatment. The recurrence rate after the treatment is similar for Vancomycin and Metronidazole and is usually in the range of 15-25%, although recent reports noted a recurrence rate up to 50% during outbreaks with a virulent strain. Recently, it has been suggested that a 2 week duration of treatment might not be adequate in clearing the infection.
Our HYPOTHESIS is that a prolongation of Vancomycin treatment from 2 weeks to 4 weeks will lead to a decrease rate of recurrent Clostridium Difficile colitis.
Read the detailed description
METHODOLOGY: Patients with a first episode of Clostridium difficile colitis will be offered a prolonged course of Vancomycin. It will be disclosed that this is not the standard of care, but that a prolonged course might decrease the relapse rate. After the initial treatment with Vancomycin 125 mg four times daily, the patients will be randomly assigned to receive either 2 weeks of Vancomycin 125 mg four times daily or 2 weeks of placebo. The placebo solution will be prepared by our pharmacy to match the color and taste of the Vancomycin solution. The initial 2 weeks of therapy for both groups will be dispensed at patients' pharmacy. Patients will be called back at the end of 2 weeks and the blinded-phase drugs will be dispensed by our pharmacy staff.
We will ask permission for a follow-up phone call at the end of treatment (1 month) and at a 3-month interval. The patients will be followed longitudinally for a 3-month period. At the end of the follow-up interval, a review of any new medical records of the patient will be made and the patient will be contacted by phone for further details.
- Conditions
- Clostridium Difficile Colitis
- Being tested
- Standard Vancomycin, Extended Vancomycin
- Keywords
- Clostridium difficile, colitis, recurrence, relapse, Vancomycin
- Medical subject headings
- Enterocolitis, Pseudomembranous, Colitis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard VancomycinDrug
Vancomycin treatment 125 mg po every 6 hours x 2 weeks
Extended VancomycinDrug
Vancomycin 125 mg every 6 hours x 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Vancomycin | Active comparator | Vancomycin 125 mg every 6 hours x 4 weeks Receives: Drug: Standard Vancomycin; Drug: Extended Vancomycin |
| Placebo | Placebo comparator | Vancomycin 125 mg every 6 hours x 2 weeks, followed by placebo every 6 hours x 2 weeks Receives: Drug: Standard Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare the incidence of recurrent Clostridium difficile-associated colitis (CDAD) after a standard 2 week versus a prolonged 4 week course of treatment with Vancomycin
Measured: 3 months
Secondary outcomes (1)
assess the response rate to Vancomycin in patients with the first episode of CDAD
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionNov 2009 (estimated)
- Study completionJan 2010 (estimated)
Why it stopped: Difficult enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Clostridium Difficile 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Collaborators
- Beaumont Hospital
- Responsible party
- Principal investigator, Mihaela Batke, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00861887
- Sponsor's protocol ID
- HIC 2008-173
- Other IDs
- RC 98690
- Status last verified
- Jan 2010
- First submitted
- 13 Mar 2009
- Last updated
- 14 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Zar FA, Bakkanagari SR, Moorthi KM, Davis MB. A comparison of vancomycin and metronidazole for the treatment of Clostridium difficile-associated diarrhea, stratified by disease severity. Clin Infect Dis. 2007 Aug 1;45(3):302-7. doi: 10.1086/519265. Epub 2007 Jun 19.
PubMed 17599306Pepin J, Alary ME, Valiquette L, Raiche E, Ruel J, Fulop K, Godin D, Bourassa C. Increasing risk of relapse after treatment of Clostridium difficile colitis in Quebec, Canada. Clin Infect Dis. 2005 Jun 1;40(11):1591-7. doi: 10.1086/430315. Epub 2005 Apr 25.
PubMed 15889355
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of 2 Weeks Versus 4 Weeks Treatment With Vancomycin for Clostridium Difficile Colitis
- ClinicalTrials.gov ID
- NCT00861887
- Acronym / sponsor ID
- HIC 2008-173
- Conditions
- Clostridium Difficile Colitis
- Keywords
- Clostridium difficile, colitis, recurrence, relapse, Vancomycin
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficult enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Collaborators
- Beaumont Hospital
- Study start
- Feb 2009
- Primary completion
- Nov 2009 (estimated)
- Study completion
- Jan 2010 (estimated)
- First posted
- 16 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
BACKGROUND: Clostridium difficile-associated colitis is an infection of the large bowel, usually associated with previous use of antibiotics. The disease course may be complicated by fulminant disease requiring removal of the colon or by multiple recurrences requiring re-hospitalization. The incidence and severity of Clostridium difficile infection is rising, and it poses an increasing burden on the health system. For example, in one of our previous studies we found that 804 in-patients and 568 out-patients had a positive test for Clostridium difficile toxin at Beaumont Laboratories in 2003. The standard treatment is a 2 week course of Vancomycin or Metronidazole. The clinical response to Metronidazole appears to be declining, and many practicing clinicians prefer Vancomycin as a first-line treatment. The recurrence rate after the treatment is similar for Vancomycin and Metronidazole and is usually in the range of 15-25%, although recent reports noted a recurrence rate up to 50% during outbreaks with a virulent strain. Recently, it has been suggested that a 2 week duration of treatment might not be adequate in clearing the infection.
Our HYPOTHESIS is that a prolongation of Vancomycin treatment from 2 weeks to 4 weeks will lead to a decrease rate of recurrent Clostridium Difficile colitis.
Detailed description
METHODOLOGY: Patients with a first episode of Clostridium difficile colitis will be offered a prolonged course of Vancomycin. It will be disclosed that this is not the standard of care, but that a prolonged course might decrease the relapse rate. After the initial treatment with Vancomycin 125 mg four times daily, the patients will be randomly assigned to receive either 2 weeks of Vancomycin 125 mg four times daily or 2 weeks of placebo. The placebo solution will be prepared by our pharmacy to match the color and taste of the Vancomycin solution. The initial 2 weeks of therapy for both groups will be dispensed at patients' pharmacy. Patients will be called back at the end of 2 weeks and the blinded-phase drugs will be dispensed by our pharmacy staff.
We will ask permission for a follow-up phone call at the end of treatment (1 month) and at a 3-month interval. The patients will be followed longitudinally for a 3-month period. At the end of the follow-up interval, a review of any new medical records of the patient will be made and the patient will be contacted by phone for further details.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vancomycin | Active comparator | Drug: Standard Vancomycin, Drug: Extended VancomycinVancomycin 125 mg every 6 hours x 4 weeks |
| Placebo | Placebo comparator | Drug: Standard VancomycinVancomycin 125 mg every 6 hours x 2 weeks, followed by placebo every 6 hours x 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- First episode of Clostridium difficile colitis, defined by a positive toxin assay plus at least one of the following: diarrhea, toxic megacolon or leukocytosis.
Key exclusion criteria (4 listed)
- previous diagnosis of Clostridium difficile colitis
- concomitant use of oral Metronidazole, Rifampin, Rifaximin, Nitazoxanide, Sacharromyce boulardii or Lactobacillus spp.
- age less than 18 years-old
- pregnancy.
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 |
|---|---|---|
| Standard VancomycinVancomycin treatment 125 mg po every 6 hours x 2 weeks | Drug | Placebo, Vancomycin |
| Extended VancomycinVancomycin 125 mg every 6 hours x 2 weeks | Drug | Vancomycin |
Primary outcome
compare the incidence of recurrent Clostridium difficile-associated colitis (CDAD) after a standard 2 week versus a prolonged 4 week course of treatment with Vancomycin
Time frame: 3 months
1 secondary outcome
assess the response rate to Vancomycin in patients with the first episode of CDAD
Time frame: 2 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2016.
- Background: PubMed 17599306Zar FA, Bakkanagari SR, Moorthi KM, Davis MB. A comparison of vancomycin and metronidazole for the treatment of Clostridium difficile-associated diarrhea, stratified by disease severity. Clin Infect Dis. 2007 Aug 1;45(3):302-7. doi: 10.1086/519265. Epub 2007 Jun 19.
- Background: PubMed 15889355Pepin J, Alary ME, Valiquette L, Raiche E, Ruel J, Fulop K, Godin D, Bourassa C. Increasing risk of relapse after treatment of Clostridium difficile colitis in Quebec, Canada. Clin Infect Dis. 2005 Jun 1;40(11):1591-7. doi: 10.1086/430315. Epub 2005 Apr 25.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Vancomycin and Extended Vancomycin in people with Clostridium Difficile 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 1 inclusion and 4 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: withdrawn, as of the sponsor's last update on 14 Dec 2016. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
compare the incidence of recurrent Clostridium difficile-associated colitis (CDAD) after a standard 2 week versus a prolonged 4 week course of treatment with Vancomycin (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00861887, which also lists 2 linked publications.
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 14 Dec 2016.