Clostridium EnterocolitisNCT00304408
Association Between Response to Treatment of C. Diff Colitis and Anti-C.Diff Toxin Antibody
An observational study of Clostridium Enterocolitis and Pseudomembranous Colitis, run by Michael E. DeBakey VA Medical Center at 1 site in United States.
Trial summary
The purpose of this study is three fold: 1)To collect serum from patients with documented Clostridium difficile infection and test for the presence of antibody to C. difficile toxin at the start and at the end of therapy, and again if a relapse or recurrence occurs. 2)To collect stool samples for test of C. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Clostridium Enterocolitis, Pseudomembranous Colitis, Antibiotic-Associated Colitis
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Jan 2008
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients positive for C. difficile.
Who may be able to join
- All patients at the Houston VA with documented C. difficile infection
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. Debakey VA Medical Center
Houston, Texas, 77030
About this study
Official title: Association Between Clinical Response of Clostridium Difficile Colitis to Treatment and Emergence of Anti-C.Difficile Toxin Antibody
The purpose of this study is three fold: 1)To collect serum from patients with documented Clostridium difficile infection and test for the presence of antibody to C. difficile toxin at the start and at the end of therapy, and again if a relapse or recurrence occurs. 2)To collect stool samples for test of C. difficile toxin at similar time intervals. 3)To assay random serum samples from the VA lab in order to determine the rate of antibody to C. difficile toxin in our patient population.
Read the detailed description
Clostridium difficile is the leading cause of nosocomial diarrheal disease associated with antibiotic therapy. This is a debilitating condition with substantial morbidity and mortality that may be around 2-3%. Current recommended therapy for this condition is metronidazole, given orally. Our observations suggest that about 10-20% of patients fail to respond to initial therapy with metronidazole, and 20% relapse after treatment. The reason why some persons are cured whereas others relapse is, at present, unknown. There is a suggestion in the medical literature that recurrent infection is associated with the failure to generate antibody to C. difficile toxin. It is also possible that those patients who become infected lack antibody, whereas others in the population tend to have such antibody. The investigators propose to study our patients at VAMC Houston in order to relate occurrence and/or the failure to respond to therapy or the appearance of recurrent disease to the presence of anti-toxin antibody. The investigators also propose to study sera obtained at random from VAMC patients in order to determine the prevalence of antibody in our patient population.
- Keywords
- Clostridium difficile
- Medical subject headings
- Enterocolitis, Pseudomembranous
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2006 (estimated)
- Study startJan 2005
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium EnterocolitisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael E. DeBakey VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Baylor College of Medicine
- Investigators
- Daniel M Musher, M.D., Principal investigator, Michael E. DeBakey VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00304408
- Sponsor's protocol ID
- H-16383
- Status last verified
- Sep 2010
- First submitted
- 16 Mar 2006
- Last updated
- 10 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Clinical Response of Clostridium Difficile Colitis to Treatment and Emergence of Anti-C.Difficile Toxin Antibody
- ClinicalTrials.gov ID
- NCT00304408
- Acronym / sponsor ID
- H-16383
- Keywords
- Clostridium difficile
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Michael E. DeBakey VA Medical CenterUS federal agency
- Collaborators
- Baylor College of Medicine
- Study start
- Jan 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 17 Mar 2006 (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.
The purpose of this study is three fold: 1)To collect serum from patients with documented Clostridium difficile infection and test for the presence of antibody to C. difficile toxin at the start and at the end of therapy, and again if a relapse or recurrence occurs. 2)To collect stool samples for test of C. difficile toxin at similar time intervals. 3)To assay random serum samples from the VA lab in order to determine the rate of antibody to C. difficile toxin in our patient population.
Detailed description
Clostridium difficile is the leading cause of nosocomial diarrheal disease associated with antibiotic therapy. This is a debilitating condition with substantial morbidity and mortality that may be around 2-3%. Current recommended therapy for this condition is metronidazole, given orally. Our observations suggest that about 10-20% of patients fail to respond to initial therapy with metronidazole, and 20% relapse after treatment. The reason why some persons are cured whereas others relapse is, at present, unknown. There is a suggestion in the medical literature that recurrent infection is associated with the failure to generate antibody to C. difficile toxin. It is also possible that those patients who become infected lack antibody, whereas others in the population tend to have such antibody. The investigators propose to study our patients at VAMC Houston in order to relate occurrence and/or the failure to respond to therapy or the appearance of recurrent disease to the presence of anti-toxin antibody. The investigators also propose to study sera obtained at random from VAMC patients in order to determine the prevalence of antibody in our patient population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients positive for C. difficile.
Key inclusion criteria (1 listed)
- All patients at the Houston VA with documented C. difficile infection
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2010.
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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.
Daniel M Musher, M.D. principal investigator
Michael E. DeBakey VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clostridium Enterocolitis and Pseudomembranous Colitis, run by Michael E. DeBakey VA Medical Center 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 1 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: finished, as of the sponsor's last update on 10 Sep 2010. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 10 Sep 2010.