Clostridium DifficileCDIFFNCT02747017
Observational Study of C. Diff in Post-Transplant Patients
An observational study of Clostridium Difficile, run by University of Minnesota at 9 sites in 5 countries.
Trial summary
The primary objective of this observational study is to estimate the 90-day response rates to treatment for a first episode of C. difficile infections (CDI) in adult transplant recipients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile
- How many people
- 132 participants
- Where
- 9 sitesin 5 countries
- Study dates
- 22 Aug 2016to 30 Oct 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with a first episode of CDI within 2 years post solid-organ or stem-cell transplant.
Who may be able to join
- Age ≥ 18 years
- Signed informed consent
- Transplant recipient (solid organ, stem cells, or bone marrow) within past 2 years
- Currently diagnosed with first CDI after transplant, defined by (1) presence of diarrhea (at least 3 loose stools within a 24-hour period), AND (2) detection of C. difficile cytotoxin in stools by cytotoxin assay, or toxigenic culture, or polymerase chain reaction (PCR) testing for toxin, or enzyme immunoassay, or endoscopic presence of pseudomembranes with the detection of C. difficile in tissue biopsies
Who cannot join
- Previous episode of CDI anytime after transplant
- Current treatment for another infectious cause of diarrhea (bacterial, viral, or parasitic) at the time of the current CDI diagnosis
Trial locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
United States4 sites
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Mayo Clinic
Rochester, Minnesota, 55905
Spain2 sites
Hospital Clinic de Barcelona
Barcelona
Hospital Universitario Doce de Octubre
Madrid
Denmark1 site
CHIP, Department of Infectious Diseases, Section 2100
Copenhagen, 2100
Germany1 site
Klinik I fur Innere Medizin der Universitat zu Koln, Studienburo fur Infektiologie u. HIV
Cologne
About this study
Official title: An International Prospective Observational Study to Assess the Characteristics and Outcomes of Post-transplant Patients Treatment for C. Difficile Infections
The primary objective of this observational study is to estimate the 90-day response rates to treatment for a first episode of C. difficile infections (CDI) in adult transplant recipients.
Read the detailed description
The primary objective of this observational study is to estimate the 90-day response rates to treatment for a first episode of C. difficile infections (CDI) in adult transplant recipients. This includes treatment success, recurrence, and complications in a prospectively followed cohort of solid organ and hematopoietic stem cell transplant patients. Patients who develop CDI within 2 years after transplantation will be enrolled and followed prospectively for 90 days after enrollment. Specimens of stool and serum collected within 48 hours of initiation of treatment will be stored locally for future epidemiologic studies to examine the immunologic and microbiologic risk factors for relapse and treatment failure, as well as complications of CDI in the transplant population. Response rates will be classified by organ type, hematopoietic stem cell transplant typ, treatment regimen, and immunosuppressive regimen.
- Conditions
- Clostridium Difficile
- Keywords
- transplant
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 |
|---|---|---|
| CDI patients | Adults with a first episode of CDI within 2 years after solid-organ or stem-cell transplant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to antibiotic treatment for CDI: clinical cure
The planned first course of CDI treatment was completed with resolution of symptoms or less than 3 loose stools per day for at least two consecutive days maintained until end of treatment and two days after treatment course ended.
Measured: 90 days
Response to antibiotic treatment for CDI: sustained clinical cure
Clinical cure achieved and maintained for 40 days post treatment initiation without recurrences, complications, ICU with CDI, or death as defined below
Measured: 90 days
Response to antibiotic treatment for CDI: global cure
Clinical cure achieved and maintained for 90 days post treatment initiation without recurrences, complications, including ICU with CDI, or death as defined below.
Measured: 90 days
Response to antibiotic treatment for CDI: relapse
A new episode of CDI after clinical cure and within 4 weeks after treatment initiation.
Measured: 90 days
Response to antibiotic treatment for CDI: reinfection
A new episode of CDI after clinical cure and beyond 4 weeks after treatment initiation
Measured: 90 days
Response to antibiotic treatment for CDI: complications
The study will collect the incidence of specific complications as assessed by the site investigator: perforation of the colon; development of toxic megacolon; need for abdominal surgery related to CDI; transfer to the ICU with CDI; death from CDI-related cause.
Measured: 90 days
Secondary outcomes (6)
Describe patients who are successfully treatment for CDI
Patients will be described by demographics (age, race, sex), type of transplant received, specific treatment for CDI, and the strain of C. difficile with which they were infected.
Measured: 90 days
Describe differences in antibiotic regimens and other CDI treatments across geographic regions (US, Europe, South America)
Measured: 90 days
All-cause mortality
Measured: 90 days
Response to treatment for CDI (as defined above) by treatment regimen
Measured: 90 days
Response to treatment for CDI (as defined above) by type of transplant (solid organ vs. hematopoietic/stem cell)
Measured: 90 days
Assay differences across sites
Describe assays used to detect C. difficile organisms and toxin in stool by site at which participants are enrolled.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study start22 Aug 2016
- Primary completion30 Oct 2018
- Study completion30 Oct 2018
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
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- International Network for Strategic Initiatives in Global HIV Trials (INSIGHT), Merck Sharp & Dohme LLC, Astellas Pharma Inc, Copenhagen HIV Programme, Medical Research Council, Washington D.C. Veterans Affairs Medical Center
- Responsible party
- Sponsor
- Investigators
- Jean-Michel Molina, MD, Study chair, Hôpital Saint-Louis, Service de Maladies Infectieuses
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747017
- Sponsor's protocol ID
- 1605M87565
- Acronym
- CDIFF
- Status last verified
- Oct 2019
- First submitted
- 12 Apr 2016
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International Prospective Observational Study to Assess the Characteristics and Outcomes of Post-transplant Patients Treatment for C. Difficile Infections
- ClinicalTrials.gov ID
- NCT02747017
- Acronym / sponsor ID
- CDIFF / 1605M87565
- Conditions
- Clostridium Difficile
- Keywords
- transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- International Network for Strategic Initiatives in Global HIV Trials (INSIGHT), Merck Sharp & Dohme LLC, Astellas Pharma Inc, Copenhagen HIV Programme, Medical Research Council, Washington D.C. Veterans Affairs Medical Center
- Study start
- 22 Aug 2016 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 21 Apr 2016 (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 primary objective of this observational study is to estimate the 90-day response rates to treatment for a first episode of C. difficile infections (CDI) in adult transplant recipients.
Detailed description
The primary objective of this observational study is to estimate the 90-day response rates to treatment for a first episode of C. difficile infections (CDI) in adult transplant recipients. This includes treatment success, recurrence, and complications in a prospectively followed cohort of solid organ and hematopoietic stem cell transplant patients. Patients who develop CDI within 2 years after transplantation will be enrolled and followed prospectively for 90 days after enrollment. Specimens of stool and serum collected within 48 hours of initiation of treatment will be stored locally for future epidemiologic studies to examine the immunologic and microbiologic risk factors for relapse and treatment failure, as well as complications of CDI in the transplant population. Response rates will be classified by organ type, hematopoietic stem cell transplant typ, treatment regimen, and immunosuppressive regimen.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CDI patients | – | –Adults with a first episode of CDI within 2 years after solid-organ or stem-cell transplant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with a first episode of CDI within 2 years post solid-organ or stem-cell transplant.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Signed informed consent
- Transplant recipient (solid organ, stem cells, or bone marrow) within past 2 years
- Currently diagnosed with first CDI after transplant, defined by (1) presence of diarrhea (at least 3 loose stools within a 24-hour period), AND (2) detection of C. difficile cytotoxin in stools by cytotoxin assay, or toxigenic culture, or polymerase chain reaction (PCR) testing for toxin, or enzyme immunoassay, or endoscopic presence of pseudomembranes with the detection of C. difficile in tissue biopsies
Key exclusion criteria (2 listed)
- Previous episode of CDI anytime after transplant
- Current treatment for another infectious cause of diarrhea (bacterial, viral, or parasitic) at the time of the current CDI diagnosis
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
Response to antibiotic treatment for CDI: clinical cure
Time frame: 90 days
The planned first course of CDI treatment was completed with resolution of symptoms or less than 3 loose stools per day for at least two consecutive days maintained until end of treatment and two days after treatment course ended.
Response to antibiotic treatment for CDI: sustained clinical cure
Time frame: 90 days
Clinical cure achieved and maintained for 40 days post treatment initiation without recurrences, complications, ICU with CDI, or death as defined below
Response to antibiotic treatment for CDI: global cure
Time frame: 90 days
Clinical cure achieved and maintained for 90 days post treatment initiation without recurrences, complications, including ICU with CDI, or death as defined below.
Response to antibiotic treatment for CDI: relapse
Time frame: 90 days
A new episode of CDI after clinical cure and within 4 weeks after treatment initiation.
Response to antibiotic treatment for CDI: reinfection
Time frame: 90 days
A new episode of CDI after clinical cure and beyond 4 weeks after treatment initiation
Response to antibiotic treatment for CDI: complications
Time frame: 90 days
The study will collect the incidence of specific complications as assessed by the site investigator: perforation of the colon; development of toxic megacolon; need for abdominal surgery related to CDI; transfer to the ICU with CDI; death from CDI-related cause.
6 secondary outcomes
Describe patients who are successfully treatment for CDI
Time frame: 90 days
Describe differences in antibiotic regimens and other CDI treatments across geographic regions (US, Europe, South America)
Time frame: 90 days
All-cause mortality
Time frame: 90 days
Response to treatment for CDI (as defined above) by treatment regimen
Time frame: 90 days
Response to treatment for CDI (as defined above) by type of transplant (solid organ vs. hematopoietic/stem cell)
Time frame: 90 days
Assay differences across sites
Time frame: 90 days
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 1 Nov 2019.
- INSIGHT network website, CDIFF home pageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Jean-Michel Molina, MD study chair
Hôpital Saint-Louis, Service de Maladies Infectieuses
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clostridium Difficile, run by University of Minnesota at 9 sites in 5 countries.
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 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 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Spain, Argentina, Denmark, Germany. 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?
Response to antibiotic treatment for CDI: clinical cure (time frame: 90 days). The study lists 6 primary outcomes in all. 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 1 Nov 2019.