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

May 15, 2024 updated by: University of Pittsburgh
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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
patients who are receiving fidaxomicin are enrolled into the study, blood is obtained for analysis, EMR and outcome data collected regarding their CDI
Other Names:
  • clostridium difficile infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
risks factors
Time Frame: "1 year"
Incidence of death as indicated in medical record
"1 year"

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CDI episodes
Time Frame: "1 year"
quantified by number of stools in a day as reported in medical record
"1 year"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Cornelius Clancy, MD, UPMC and PITT

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Actual)

May 1, 2023

Study Completion (Actual)

May 1, 2023

Study Registration Dates

First Submitted

August 13, 2019

First Submitted That Met QC Criteria

August 23, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

May 17, 2024

Last Update Submitted That Met QC Criteria

May 15, 2024

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO18110022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

This is a pilot project. research data/samples may be shared with investigators conducting other research; this information will be shared without identifiable information. If such will occur appropriate regulatory documentation such as DUA or MTA's will be put in place prior to sharing of data and biological samples

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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