Clostridium Difficile Infection (CDI)
Conditions
Brief summary
This is a single center collection of discarded biological samples and electronic medical review (EMR) data on patients who are hospitalized with clostridium difficile infections and treated with Fidaxomicin
Detailed description
This single site study will be a clinical research data base of patients hospitalized and diagnosed with Clostridium difficile infection (CDI), treated with Fidaxomicin and willing to allow us to collect discard biological samples for testing and analysis in the investigators lab. An additional blood sample will be obtained if a clinically indicated bronchoscopy is performed as to measure the amount of medication in the BAL. We will also complete a medical record review will also occur.
Interventions
DRUGFidaxomicin
patients who are receiving fidaxomicin are enrolled into the study, blood is obtained for analysis, EMR and outcome data collected regarding their CDI
Sponsors
Merck Sharp & Dohme LLC
University of Pittsburgh
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥18 years of age 2. Currently an inpatient at UPMC Presbyterian 3. Diagnosed with an CDI 4. Being treated with Fidaxomicin
Exclusion criteria
not meeting entry criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| risks factors | 1 year | Incidence of death as indicated in medical record |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CDI episodes | 1 year | quantified by number of stools in a day as reported in medical record |
Countries
United States
Outcome results
None listed