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

NCT04070352 | Withdrawn DMC FDA Drug

• 1 other identifier: PRO18110022
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Clostridium Difficile Infection (CDI)

Outcome Measures

Primary Outcomes (1)

• risks factors

  Incidence of death as indicated in medical record

  "1 year"

Secondary Outcomes (1)

• CDI episodes

  "1 year"

Study Arms (1)

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

Drug: Fidaxomicin

Interventions

Fidaxomicin DRUG

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

Also known as: clostridium difficile infection

clostridium difficile infection (CDI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with CDI and treated with fidaxomicin and seen at PUH

You may qualify if:

• ≥18 years of age
• Currently an inpatient at UPMC Presbyterian
• Diagnosed with an CDI
• Being treated with Fidaxomicin

You may not qualify if:

• not meeting entry criteria

Sponsors & Collaborators

• University of Pittsburgh: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (5)

• 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.

  PMID: 22726461 RESULT

• 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.

  PMID: 29336929 RESULT

• 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.

  PMID: 25096079 RESULT

• 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.

  PMID: 29512244 RESULT

• 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.

  PMID: 29800295 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

All discarded biological samples collected as part of the patient's clinical care to include blood, urine, BAL, tissue, etc. Additionally a blood sample is obtained for genetic testing and CDI analysis

MeSH Terms

Conditions

Clostridium Infections

Interventions

Fidaxomicin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Polyketides; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Cornelius Clancy, MD

  UPMC and PITT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: August 28, 2019
• Study Start: August 1, 2019
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: May 17, 2024

Record last verified: 2022-06

Locations

US (1)