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

Clostridium Difficile Infection (CDI) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04070352
• Other study ID #: PRO18110022
• Status: Withdrawn
• Start date: August 1, 2019
• Est. completion date: May 1, 2023

Study information

• Verified date: June 2022
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Clostridium Difficile Infection (CDI)
• Clostridium Infections
• Communicable Diseases
• Infections

Intervention

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

Locations

Country	Name	City	State
United States	UPMC	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

References & Publications (5)

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):252 — View Citation

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. — View Citation

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 20 — View Citation

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 — View Citation

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 Infe — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	risks factors	Incidence of death as indicated in medical record	"1 year"
Secondary	CDI episodes	quantified by number of stools in a day as reported in medical record	"1 year"