Clostridium DifficileNCT02063282
The Risk for Clostridium Difficile Colitis During Hospitalization in Asymptomatic Carriers
An observational study of Clostridium Difficile and Colitis, run by Amos Yinnon at 1 site in Israel.
Trial summary
The investigators hypothesize that development of symptoms characteristic of Clostridium difficile infection will be 2-3 times higher in asymptomatic carriers, compared to that of non carriers and expect to find risk factors for development of symptomatic clostridium difficile. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Clostridium Difficile, Colitis
- How many people
- 394 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2014to Dec 2014
- How long will I take part?
- 2 Weeks
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Newly admitted patients in the Emergency Department and Internal wards, .
Who may be able to join
- History of hospitalization in recent year, residence of a nursing home or institutions
- Expected more than 48 hours hospitalization
Who cannot join
- Colitis/ diarrhea
- Rectal swab performed ≥48 hrs post arrival to hospital.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators hypothesize that development of symptoms characteristic of Clostridium difficile infection will be 2-3 times higher in asymptomatic carriers, compared to that of non carriers and expect to find risk factors for development of symptomatic clostridium difficile.
- Conditions
- Clostridium Difficile, Colitis
- Keywords
- Asymptomatic, Carriage, Colonization, Clostridium difficile, Colitis, Rectal swab
- Medical subject headings
- Colitis
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 |
|---|---|---|
| Clostridium difficile carriers | Not described | |
| Clostridium difficile non carriers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of colitis
participants will be followed for the duration of hospital stay, an expected average of 4 weeks.
Patients' file will be reviewed and the next signs and symptoms will be recorded: abdominal pain, diarrhea, fever and leukocytosis.
Measured: Daily follow-up
Secondary outcomes (2)
Duration until development of colitis
participants will be followed for the duration of hospital stay, an expected average of 4 weeks.
Patients' file will be reviewed and the next signs and symptoms will be recorded: abdominal pain, diarrhea, fever and leukocytosis.
Measured: Daily follow-up
Severity of colitis
participants will be followed for the duration of hospital stay, an expected average of 4 weeks.
Patients' file will be reviewed and the next signs and symptoms will be recorded: abdominal pain, diarrhea, fever and leukocytosis.
Measured: Daily follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium DifficileStudies 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
- 394 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Amos Yinnon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amos Yinnon, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063282
- Sponsor's protocol ID
- ShaareZMC
- Status last verified
- Apr 2016
- First submitted
- 11 Feb 2014
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Risk for Clostridium Difficile Colitis During Hospitalization in Asymptomatic Carriers
- ClinicalTrials.gov ID
- NCT02063282
- Acronym / sponsor ID
- ShaareZMC
- Conditions
- Clostridium Difficile, Colitis
- Keywords
- Asymptomatic, Carriage, Colonization, Clostridium difficile, Colitis, Rectal swab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 394 participants (actual)
- Lead sponsor
- Amos YinnonUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 14 Feb 2014 (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 investigators hypothesize that development of symptoms characteristic of Clostridium difficile infection will be 2-3 times higher in asymptomatic carriers, compared to that of non carriers and expect to find risk factors for development of symptomatic clostridium difficile.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clostridium difficile carriers | – | – |
| Clostridium difficile non carriers | – | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Newly admitted patients in the Emergency Department and Internal wards, .
Key inclusion criteria (2 listed)
- History of hospitalization in recent year, residence of a nursing home or institutions
- Expected more than 48 hours hospitalization
Key exclusion criteria (2 listed)
- Colitis/ diarrhea
- Rectal swab performed ≥48 hrs post arrival to hospital.
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
Development of colitis
Time frame: Daily follow-up
participants will be followed for the duration of hospital stay, an expected average of 4 weeks. Patients' file will be reviewed and the next signs and symptoms will be recorded: abdominal pain, diarrhea, fever and leukocytosis.
2 secondary outcomes
Duration until development of colitis
Time frame: Daily follow-up
Severity of colitis
Time frame: Daily follow-up
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 21 Apr 2016.
- Related InfoLink provided by the sponsor.
- 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?
An observational study of Clostridium Difficile and Colitis, run by Amos Yinnon at 1 site in Israel.
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 2 inclusion and 2 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 21 Apr 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 Israel. 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?
Development of colitis (time frame: Daily follow-up). 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 21 Apr 2016.