Evaluation of Fidaxomicin in the Treatment of Clostridium Difficile Infection (CDI)

Overview

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2024

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

  • Drug: Fidaxomicin
    • patients who are receiving fidaxomicin are enrolled into the study, blood is obtained for analysis, EMR and outcome data collected regarding their CDI

Arms, Groups and Cohorts

  • clostridium difficile infection (CDI)
    • 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

Clinical Trial Outcome Measures

Primary Measures

  • risks factors
    • Time Frame: “1 year”
    • Incidence of death as indicated in medical record

Secondary Measures

  • CDI episodes
    • Time Frame: “1 year”
    • quantified by number of stools in a day as reported in medical record

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cornelius Clancy
  • Collaborator
    • Merck Sharp & Dohme LLC
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Cornelius Clancy, Associate Professor – University of Pittsburgh
  • Overall Official(s)
    • Cornelius Clancy, MD, Principal Investigator, UPMC and PITT

Citations Reporting on Results

Pant C, Anderson MP, O'Connor JA, Marshall CM, Deshpande A, Sferra TJ. Association of Clostridium difficile infection with outcomes of hospitalized solid organ transplant recipients: results from the 2009 Nationwide Inpatient Sample database. Transpl Infect Dis. 2012 Oct;14(5):540-7. doi: 10.1111/j.1399-3062.2012.00761.x. Epub 2012 Jun 22.

Heimann SM, Cruz Aguilar MR, Mellinghof S, Vehreschild MJGT. Economic burden and cost-effective management of Clostridium difficile infections. Med Mal Infect. 2018 Feb;48(1):23-29. doi: 10.1016/j.medmal.2017.10.010. Epub 2018 Jan 12.

Nathwani D, Cornely OA, Van Engen AK, Odufowora-Sita O, Retsa P, Odeyemi IA. Cost-effectiveness analysis of fidaxomicin versus vancomycin in Clostridium difficile infection. J Antimicrob Chemother. 2014 Nov;69(11):2901-12. doi: 10.1093/jac/dku257. Epub 2014 Aug 5.

Nguyen CT, Li J, Anders S, Garcia-Diaz J, Staffeld-Coit C, Hand J. Comparison of outcomes with vancomycin or metronidazole for mild-to-moderate Clostridium difficile associated diarrhea among solid organ transplant recipients: A retrospective cohort study. Transpl Infect Dis. 2018 Jun;20(3):e12867. doi: 10.1111/tid.12867. Epub 2018 Mar 30.

Cornely OA, Watt M, McCrea C, Goldenberg SD, De Nigris E. Extended-pulsed fidaxomicin versus vancomycin for Clostridium difficile infection in patients aged >/=60 years (EXTEND): analysis of cost-effectiveness. J Antimicrob Chemother. 2018 Sep 1;73(9):2529-2539. doi: 10.1093/jac/dky184.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.