Evaluation of Fidaxomicin in the Treatment of Clostridium Difficile Infection (CDI)
NCT ID: NCT04070352
Last Updated: 2024-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2019-08-01
2023-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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
Fidaxomicin
patients who are receiving fidaxomicin are enrolled into the study, blood is obtained for analysis, EMR and outcome data collected regarding their CDI
Interventions
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Fidaxomicin
patients who are receiving fidaxomicin are enrolled into the study, blood is obtained for analysis, EMR and outcome data collected regarding their CDI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Currently an inpatient at UPMC Presbyterian
3. Diagnosed with an CDI
4. Being treated with Fidaxomicin
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
University of Pittsburgh
OTHER
Responsible Party
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Principal Investigators
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Cornelius Clancy, MD
Role: PRINCIPAL_INVESTIGATOR
UPMC and PITT
Locations
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UPMC
Pittsburgh, Pennsylvania, United States
Countries
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References
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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.
Other Identifiers
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PRO18110022
Identifier Type: -
Identifier Source: org_study_id
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