Observational Study of C. Diff in Post-Transplant Patients

Clostridium Difficile Clinical Trial

— CDIFF  

Official title:

An International Prospective Observational Study to Assess the Characteristics and Outcomes of Post-transplant Patients Treatment for C. Difficile Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02747017
• Other study ID #: 1605M87565
• Status: Completed
• Start date: August 22, 2016
• Est. completion date: October 30, 2018

Study information

• Verified date: October 2019
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: October 30, 2018
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Clostridium Difficile

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires	Buenos Aires
Denmark	CHIP, Department of Infectious Diseases, Section 2100	Copenhagen
Germany	Klinik I fur Innere Medizin der Universitat zu Koln, Studienburo fur Infektiologie u. HIV	Cologne
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital Universitario Doce de Octubre	Madrid
United States	University of Minnesota Medical Center	Minneapolis	Minnesota
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (7)

Lead Sponsor	Collaborator
University of Minnesota	Astellas Pharma Inc, Copenhagen HIV Programme, International Network for Strategic Initiatives in Global HIV Trials (INSIGHT), Medical Research Council, Merck Sharp & Dohme Corp., Washington D.C. Veterans Affairs Medical Center

Countries where clinical trial is conducted

United States,  Argentina,  Denmark,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	90 days
Primary	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	90 days
Primary	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.	90 days
Primary	Response to antibiotic treatment for CDI: relapse	A new episode of CDI after clinical cure and within 4 weeks after treatment initiation.	90 days
Primary	Response to antibiotic treatment for CDI: reinfection	A new episode of CDI after clinical cure and beyond 4 weeks after treatment initiation	90 days
Primary	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.	90 days
Secondary	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.	90 days
Secondary	Describe differences in antibiotic regimens and other CDI treatments across geographic regions (US, Europe, South America)		90 days
Secondary	All-cause mortality		90 days
Secondary	Response to treatment for CDI (as defined above) by treatment regimen		90 days
Secondary	Response to treatment for CDI (as defined above) by type of transplant (solid organ vs. hematopoietic/stem cell)		90 days
Secondary	Assay differences across sites	Describe assays used to detect C. difficile organisms and toxin in stool by site at which participants are enrolled.	90 days

External Links

•   INSIGHT network website, CDIFF home page