Evaluation of Fidaxomicin in the Treatment of Clostridium Difficile Infection (CDI)
- Registration Number
- NCT04070352
- Lead Sponsor
- University of Pittsburgh
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- ≥18 years of age
- Currently an inpatient at UPMC Presbyterian
- Diagnosed with an CDI
- Being treated with Fidaxomicin
not meeting entry criteria
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description clostridium difficile infection (CDI) Fidaxomicin This is a pilot project. Data from electronic medical records will be collected on all patients diagnosed with clostridium difficile infection and who are receiving fidaxomicin as part of their treatment. A total of 50 patients will be enrolled
- Primary Outcome Measures
Name Time Method risks factors "1 year" Incidence of death as indicated in medical record
- Secondary Outcome Measures
Name Time Method CDI episodes "1 year" quantified by number of stools in a day as reported in medical record
Trial Locations
- Locations (1)
UPMC
🇺🇸Pittsburgh, Pennsylvania, United States