Clinical trial NCT02747017: Observational Study of C. Diff in Post-Transplant Patients
Official title: An International Prospective Observational Study to Assess the Characteristics and Outcomes of Post-transplant Patients Treatment for C. Difficile Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clostridium Difficile
Keywords: transplant
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
name: Merck Sharp & Dohme LLC
name: Astellas Pharma Inc
name: Copenhagen HIV Programme
name: Medical Research Council
name: Washington D.C. Veterans Affairs Medical Center
First posted: 2016-04-21
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with a first episode of CDI within 2 years post solid-organ or stem-cell transplant.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Response to antibiotic treatment for CDI: clinical cure
timeFrame: 90 days
measure: Response to antibiotic treatment for CDI: sustained clinical cure
timeFrame: 90 days
measure: Response to antibiotic treatment for CDI: global cure
timeFrame: 90 days
measure: Response to antibiotic treatment for CDI: relapse
timeFrame: 90 days
measure: Response to antibiotic treatment for CDI: reinfection
timeFrame: 90 days
measure: Response to antibiotic treatment for CDI: complications
timeFrame: 90 days
Secondary outcomes:
measure: Describe patients who are successfully treatment for CDI
timeFrame: 90 days
measure: Describe differences in antibiotic regimens and other CDI treatments across geographic regions (US, Europe, South America)
timeFrame: 90 days
measure: All-cause mortality
timeFrame: 90 days
measure: Response to treatment for CDI (as defined above) by treatment regimen
timeFrame: 90 days
measure: Response to treatment for CDI (as defined above) by type of transplant (solid organ vs. hematopoietic/stem cell)
timeFrame: 90 days
measure: Assay differences across sites
timeFrame: 90 days
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Copenhagen
country: Denmark
facility: CHIP, Department of Infectious Diseases, Section 2100
city: Cologne
country: Germany
facility: Klinik I fur Innere Medizin der Universitat zu Koln, Studienburo fur Infektiologie u. HIV
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario Doce de Octubre
Study officials:
affiliation: Hôpital Saint-Louis, Service de Maladies Infectieuses
name: Jean-Michel Molina, MD
role: STUDY_CHAIR
References: