Clostridium Difficile InfectionNCT01560832
Descriptive Epidemiology of Clostridium Difficile Infection in Hospitalized Adult Patients in the Asia Pacific Region
An observational study of Clostridium Difficile Infection, run by Yonsei University at 1 site in South Korea.
Trial summary
Clostridium difficile is an important pathogen, causing disease that ranges from mild self-limited diarrhea to life-threatening pseudomembranous colitis. It is estimated that C. difficile is responsible for 10% to 25% of all cases of antibiotic-associated diarrhea and for almost all cases of pseudomembranous colitis. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Clostridium Difficile Infection
- How many people
- 188 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2011to Jun 2012
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient who has experienced the passage of 3 or more unformed or loose stools [diarrhea] conforming to the shape of a container within a 24-hour period and has a positive laboratory test result confirmed by PCR.
Who may be able to join
- Adult patients, aged ≥ 20 years at the time of hospitalization in specified wards
- PCR-diagnosed CDI while at the hospital
- Informed consent has been obtained from patients as required by local requirements
Who cannot join
- Age < 20 years
Trial locations and contacts
1 site in 1 country.
About this study
Clostridium difficile is an important pathogen, causing disease that ranges from mild self-limited diarrhea to life-threatening pseudomembranous colitis. It is estimated that C. difficile is responsible for 10% to 25% of all cases of antibiotic-associated diarrhea and for almost all cases of pseudomembranous colitis. C. difficile disease is mediated by two large toxins, A and B. The toxins damage intestinal epithelial cells and cause the clinical illness. Primary risk factors for C. difficile clinically apparent infection include antimicrobial therapy, hospitalization, residence in a long-term care facility, older age (≥ 65 years), and increased length of hospital stay. The incidence of CDI both in the hospital and the community is important in the understanding and characterization of the disease and its prevention. This observational, epidemiological study will advance the investigators understanding of CDI risk factors in several hospitals and possibly the community in the Asia Pacific region.
- Conditions
- Clostridium Difficile Infection
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Laboratory (PCR)-confirmed C.difficile infection | patient who has experienced the passage of 3 or more unformed or loose stools [diarrhea] conforming to the shape of a container within a 24-hour period and has a positive laboratory test result confirmed by PCR. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the incidence of laboratory-confirmed hospital-onset CDI cases for hospitalized adult patients
A laboratory-confirmed CDI case is defined as a patient who has experienced the passage of 3 or more unformed or loose stools [diarrhea] conforming to the shape of a container within a 24-hour period and has a positive laboratory test result confirmed by PCR. A hospital onset case is defined as a patient with diarrhea more than 48 hours after admission to a hospital.
The study period is the study duration, which is defined as the first date of surveillance at each hospital until the sample collection date of the last CDI positive patient (N=100).
Measured: every 5 days after consented to enroll the exam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2012 (estimated)
- Study startDec 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Clostridium Difficile InfectionStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01560832
- Sponsor's protocol ID
- 4-2011-0382
- Status last verified
- Mar 2014
- First submitted
- 2 Mar 2012
- Last updated
- 5 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Gerding DN, Olson MM, Peterson LR, Teasley DG, Gebhard RL, Schwartz ML, Lee JT Jr. Clostridium difficile-associated diarrhea and colitis in adults. A prospective case-controlled epidemiologic study. Arch Intern Med. 1986 Jan;146(1):95-100.
PubMed 3942469Anand A, Bashey B, Mir T, Glatt AE. Epidemiology, clinical manifestations, and outcome of Clostridium difficile-associated diarrhea. Am J Gastroenterol. 1994 Apr;89(4):519-23.
PubMed 8147353Bartlett JG. Clostridium difficile: history of its role as an enteric pathogen and the current state of knowledge about the organism. Clin Infect Dis. 1994 May;18 Suppl 4:S265-72. doi: 10.1093/clinids/18.supplement_4.s265.
PubMed 8086574McDonald LC, Coignard B, Dubberke E, Song X, Horan T, Kutty PK; Ad Hoc Clostridium difficile Surveillance Working Group. Recommendations for surveillance of Clostridium difficile-associated disease. Infect Control Hosp Epidemiol. 2007 Feb;28(2):140-5. doi: 10.1086/511798. Epub 2007 Jan 25.
PubMed 17265394Zar 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 17599306
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Epidemiology of Clostridium Difficile Infection in Hospitalized Adult Patients in the Asia Pacific Region
- ClinicalTrials.gov ID
- NCT01560832
- Acronym / sponsor ID
- 4-2011-0382
- Conditions
- Clostridium Difficile Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 22 Mar 2012 (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.
Clostridium difficile is an important pathogen, causing disease that ranges from mild self-limited diarrhea to life-threatening pseudomembranous colitis. It is estimated that C. difficile is responsible for 10% to 25% of all cases of antibiotic-associated diarrhea and for almost all cases of pseudomembranous colitis. C. difficile disease is mediated by two large toxins, A and B. The toxins damage intestinal epithelial cells and cause the clinical illness. Primary risk factors for C. difficile clinically apparent infection include antimicrobial therapy, hospitalization, residence in a long-term care facility, older age (≥ 65 years), and increased length of hospital stay. The incidence of CDI both in the hospital and the community is important in the understanding and characterization of the disease and its prevention. This observational, epidemiological study will advance the investigators understanding of CDI risk factors in several hospitals and possibly the community in the Asia Pacific region.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laboratory (PCR)-confirmed C.difficile infection | – | –patient who has experienced the passage of 3 or more unformed or loose stools [diarrhea] conforming to the shape of a container within a 24-hour period and has a positive laboratory test result confirmed by PCR. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient who has experienced the passage of 3 or more unformed or loose stools [diarrhea] conforming to the shape of a container within a 24-hour period and has a positive laboratory test result confirmed by PCR.
Key inclusion criteria (3 listed)
- Adult patients, aged ≥ 20 years at the time of hospitalization in specified wards
- PCR-diagnosed CDI while at the hospital
- Informed consent has been obtained from patients as required by local requirements
Key exclusion criteria (1 listed)
- Age < 20 years
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
To estimate the incidence of laboratory-confirmed hospital-onset CDI cases for hospitalized adult patients
Time frame: every 5 days after consented to enroll the exam
A laboratory-confirmed CDI case is defined as a patient who has experienced the passage of 3 or more unformed or loose stools [diarrhea] conforming to the shape of a container within a 24-hour period and has a positive laboratory test result confirmed by PCR. A hospital onset case is defined as a patient with diarrhea more than 48 hours after admission to a hospital. The study period is the study duration, which is defined as the first date of surveillance at each hospital until the sample collection date of the last CDI positive patient (N=100).
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 5 Mar 2014.
- Background: PubMed 3942469Gerding DN, Olson MM, Peterson LR, Teasley DG, Gebhard RL, Schwartz ML, Lee JT Jr. Clostridium difficile-associated diarrhea and colitis in adults. A prospective case-controlled epidemiologic study. Arch Intern Med. 1986 Jan;146(1):95-100.
- Background: PubMed 8147353Anand A, Bashey B, Mir T, Glatt AE. Epidemiology, clinical manifestations, and outcome of Clostridium difficile-associated diarrhea. Am J Gastroenterol. 1994 Apr;89(4):519-23.
- Background: PubMed 8086574Bartlett JG. Clostridium difficile: history of its role as an enteric pathogen and the current state of knowledge about the organism. Clin Infect Dis. 1994 May;18 Suppl 4:S265-72. doi: 10.1093/clinids/18.supplement_4.s265.
- Background: PubMed 17265394McDonald LC, Coignard B, Dubberke E, Song X, Horan T, Kutty PK; Ad Hoc Clostridium difficile Surveillance Working Group. Recommendations for surveillance of Clostridium difficile-associated disease. Infect Control Hosp Epidemiol. 2007 Feb;28(2):140-5. doi: 10.1086/511798. Epub 2007 Jan 25.
- 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.
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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?
An observational study of Clostridium Difficile Infection, run by Yonsei University at 1 site in South Korea.
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 3 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 5 Mar 2014. 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 South Korea. 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.
What does the primary outcome measure?
To estimate the incidence of laboratory-confirmed hospital-onset CDI cases for hospitalized adult patients (time frame: every 5 days after consented to enroll the exam). 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 NCT01560832, which also lists 5 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 5 Mar 2014.