Clostridium Difficile Infection (CDI)NCT04070352
Evaluation of Fidaxomicin in the Treatment of Clostridium Difficile Infection (CDI)
An observational study of Clostridium Difficile Infection (CDI), run by University of Pittsburgh at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile Infection (CDI)
- What is being tested?
- Fidaxomicin
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 1 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with CDI and treated with fidaxomicin and seen at PUH
Who may be able to join
- ≥18 years of age
- Currently an inpatient at UPMC Presbyterian
- Diagnosed with an CDI
- Being treated with Fidaxomicin
Who cannot join
- not meeting entry criteria
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Clostridium Difficile Infection (CDI)
- Being tested
- Fidaxomicin
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FidaxomicinDrug
Also called clostridium difficile infection
patients who are receiving fidaxomicin are enrolled into the study, blood is obtained for analysis, EMR and outcome data collected regarding their CDI
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Fidaxomicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
risks factors
Incidence of death as indicated in medical record
Measured: "1 year"
Secondary outcomes (1)
CDI episodes
quantified by number of stools in a day as reported in medical record
Measured: "1 year"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Aug 2019
- Primary completion1 May 2023
- Study completion1 May 2023
Why it stopped: no patients enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Clostridium Difficile Infection (CDI)Studies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Cornelius Clancy, MD, Principal investigator, UPMC and PITT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04070352
- Sponsor's protocol ID
- PRO18110022
- Status last verified
- Jun 2022
- First submitted
- 13 Aug 2019
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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
Publications
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.
PubMed 22726461Heimann 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.
PubMed 29336929Nathwani 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.
PubMed 25096079Nguyen 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.
PubMed 29512244Cornely 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.
PubMed 29800295
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fidaxomicin in the Treatment of Clostridium Difficile Infection (CDI)
- ClinicalTrials.gov ID
- NCT04070352
- Acronym / sponsor ID
- PRO18110022
- Conditions
- Clostridium Difficile Infection (CDI)
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no patients enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| clostridium difficile infection (CDI) | – | Drug: FidaxomicinThis 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with CDI and treated with fidaxomicin and seen at PUH
Key inclusion criteria (4 listed)
- ≥18 years of age
- Currently an inpatient at UPMC Presbyterian
- Diagnosed with an CDI
- Being treated with Fidaxomicin
Key exclusion criteria (1 listed)
- not meeting entry criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FidaxomicinAlso: clostridium difficile infectionpatients who are receiving fidaxomicin are enrolled into the study, blood is obtained for analysis, EMR and outcome data collected regarding their CDI | Drug | clostridium difficile infection (CDI) |
Primary outcome
risks factors
Time frame: "1 year"
Incidence of death as indicated in medical record
1 secondary outcome
CDI episodes
Time frame: "1 year"
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Results publication: PubMed 22726461Pant 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.
- Results publication: PubMed 29336929Heimann 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.
- Results publication: PubMed 25096079Nathwani 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.
- Results publication: PubMed 29512244Nguyen 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.
- Results publication: PubMed 29800295Cornely 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.
- Individual participant dataSharing planned: Undecided. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cornelius Clancy, MD principal investigator
UPMC and PITT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clostridium Difficile Infection (CDI), run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
risks factors (time frame: "1 year"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04070352, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.