Clostridium Difficile InfectionNCT02461901
Does Fidaxomicin Therapy Reduce Spread of Clostridium Difficile?
An observational study of Clostridium Difficile Infection, run by Professor Mark Wilcox at 3 sites in United Kingdom.
Trial summary
This study evaluates whether patients with Clostridium difficile infection (CDI) who are treated with fidaxomicin have less contamination of their skin and surrounding environment with spores of C. difficile than patients treated with other drugs (metronidazole or vancomycin) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile Infection
- What is being tested?
- Environmental sampling, Skin swab sampling and Fecal sampling
- How many people
- 203 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Jan 2015to Dec 2017
- 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 with Clostridium difficile infection. CDI is defined as the presence of both: * a positive C. difficile toxin assay result on a fecal sample, and * diarrhea (Bristol stool type 5-7) >/= 3 times in any 24 hour period in the last 7 days
Who may be able to join
- Diagnosis of CDI (see above)
- Prescribed fidaxomicin, vancomycin or metronidazole by attending physician
Who cannot join
- Patients whose clinical care team indicates it would be inappropriate to include him/her in the study (e.g. due to terminal illness)
- In a patient receiving metronidazole or vancomycin, receipt of fidaxomicin within the previous 3 months
- patients unable to give informed consent for whom no consultee is available to give approval
- non-English speakers
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, West Yorkshire, BD9 6RJ
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, LS1 3EX
St George's University Hospitals NHS Foundation Trust
Tooting, London, SW19 0QT
About this study
Official title: Does Using Fidaxomicin to Treat Clostridium Difficile Infection (CDI) Reduce the Recovery of C. Difficile From Patients' Faeces, Skin and Their Immediate Environment, Compared to Treatment With Vancomycin or Metronidazole?
This study evaluates whether patients with Clostridium difficile infection (CDI) who are treated with fidaxomicin have less contamination of their skin and surrounding environment with spores of C. difficile than patients treated with other drugs (metronidazole or vancomycin)
Read the detailed description
Fidaxomicin is a newly licensed drug for the treatment of CDI. Patients treated with fidaxomicin have a significantly lower C. difficile spore count in their faeces than patients who receive alternative drugs (metronidazole or vancomycin). In vitro evidence has shown that the drug persists in the gut for several weeks after treatment has finished and also prevents the outgrowth of spores. These findings suggest that fidaxomicin therapy could be associated with less contamination of CDI patient's skin and their surrounding environment than metronidazole or vancomycin therapy.
This prospective, case control study aims to investigate this hypothesis by measuring C. difficile spore counts in patient's stool samples, on their skin and in the surrounding environment. Results for patients receiving fidaxomicin will be compared with those on either metronidazole or vancomycin.
If fidaxomicin therapy does reduce contamination levels, it might be a useful adjunct to existing measures used to control CDI in healthcare settings, particularly in outbreak situations.
- Conditions
- Clostridium Difficile Infection
- Being tested
- Environmental sampling, Skin swab sampling, Fecal sampling
- Keywords
- clostridium difficile, environment, contamination, 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.
Environmental samplingOther
Sampling of five sites in the patient's immediate environment for C. difficile spores
Skin swab samplingOther
Collection of swabs from three sites on the skin for C. difficile spores
Fecal samplingOther
Collection of fecal samples for C. difficile spores
| Study group | Role | What they receive |
|---|---|---|
| Fidaxomicin treatment | Patients being treat with fidaxomicin (on the decision of their treating physician) Receives: Other: Environmental sampling; Other: Skin swab sampling; Other: Fecal sampling | |
| Metronidazole or vancomycin treatment | Patients being treated with metronidazole or vancomycin (on the decision of their treating physician) Receives: Other: Environmental sampling; Other: Skin swab sampling; Other: Fecal sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence of environmental contamination with C. difficile spores during and following treatment with fidaxomicin, vancomycin or metronidazole.
Measured: Up to 28 days after treatment
The presence of skin contamination with C. difficile spores during and following treatment with fidaxomicin, vancomycin or metronidazole.
Measured: Up to 28 days after treatment
Secondary outcomes (2)
C.difficile spore counts in the faeces of CDI patients before, during and after treatment with fidaxomicin, vancomycin or metronidazole.
Measured: Up to 28 days after treatment
Total C. difficile spore counts from skin swab samples during and following treatment with fidaxomicin, vancomycin or metronidazole.
Measured: Up to 28 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study startJan 2015
- Primary completion31 Dec 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium Difficile InfectionStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Professor Mark Wilcox
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Europe Ltd., The Leeds Teaching Hospitals NHS Trust, St George's Healthcare NHS Trust
- Responsible party
- Sponsor-investigator, Professor Mark Wilcox, University of Leeds
- Investigators
- Mark H Wilcox, Study chair, Leeds Teaching Hospitals NHS TrustTim Planche, Principal investigator, St George's Healthcare NHS TrustPhilip Stanley, Principal investigator, Bradford Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02461901
- Sponsor's protocol ID
- 14/NW/1398
- Status last verified
- Sep 2021
- First submitted
- 1 Jun 2015
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Using Fidaxomicin to Treat Clostridium Difficile Infection (CDI) Reduce the Recovery of C. Difficile From Patients' Faeces, Skin and Their Immediate Environment, Compared to Treatment With Vancomycin or Metronidazole?
- ClinicalTrials.gov ID
- NCT02461901
- Acronym / sponsor ID
- 14/NW/1398
- Conditions
- Clostridium Difficile Infection
- Keywords
- clostridium difficile, environment, contamination, fidaxomicin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Professor Mark WilcoxUniversity, hospital or other
- Collaborators
- Astellas Pharma Europe Ltd., The Leeds Teaching Hospitals NHS Trust, St George's Healthcare NHS Trust
- Study start
- Jan 2015
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 3 Jun 2015 (estimated)
- 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 study evaluates whether patients with Clostridium difficile infection (CDI) who are treated with fidaxomicin have less contamination of their skin and surrounding environment with spores of C. difficile than patients treated with other drugs (metronidazole or vancomycin)
Detailed description
Fidaxomicin is a newly licensed drug for the treatment of CDI. Patients treated with fidaxomicin have a significantly lower C. difficile spore count in their faeces than patients who receive alternative drugs (metronidazole or vancomycin). In vitro evidence has shown that the drug persists in the gut for several weeks after treatment has finished and also prevents the outgrowth of spores. These findings suggest that fidaxomicin therapy could be associated with less contamination of CDI patient's skin and their surrounding environment than metronidazole or vancomycin therapy.
This prospective, case control study aims to investigate this hypothesis by measuring C. difficile spore counts in patient's stool samples, on their skin and in the surrounding environment. Results for patients receiving fidaxomicin will be compared with those on either metronidazole or vancomycin.
If fidaxomicin therapy does reduce contamination levels, it might be a useful adjunct to existing measures used to control CDI in healthcare settings, particularly in outbreak situations.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fidaxomicin treatment | – | Other: Environmental sampling, Other: Skin swab sampling, Other: Fecal samplingPatients being treat with fidaxomicin (on the decision of their treating physician) |
| Metronidazole or vancomycin treatment | – | Other: Environmental sampling, Other: Skin swab sampling, Other: Fecal samplingPatients being treated with metronidazole or vancomycin (on the decision of their treating physician) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Clostridium difficile infection. CDI is defined as the presence of both: * a positive C. difficile toxin assay result on a fecal sample, and * diarrhea (Bristol stool type 5-7) >/= 3 times in any 24 hour period in the last 7 days
Key inclusion criteria (2 listed)
- Diagnosis of CDI (see above)
- Prescribed fidaxomicin, vancomycin or metronidazole by attending physician
Key exclusion criteria (4 listed)
- Patients whose clinical care team indicates it would be inappropriate to include him/her in the study (e.g. due to terminal illness)
- In a patient receiving metronidazole or vancomycin, receipt of fidaxomicin within the previous 3 months
- patients unable to give informed consent for whom no consultee is available to give approval
- non-English speakers
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 |
|---|---|---|
| Environmental samplingSampling of five sites in the patient's immediate environment for C. difficile spores | Other | Fidaxomicin treatment, Metronidazole or vancomycin treatment |
| Skin swab samplingCollection of swabs from three sites on the skin for C. difficile spores | Other | Fidaxomicin treatment, Metronidazole or vancomycin treatment |
| Fecal samplingCollection of fecal samples for C. difficile spores | Other | Fidaxomicin treatment, Metronidazole or vancomycin treatment |
Primary outcome
The presence of environmental contamination with C. difficile spores during and following treatment with fidaxomicin, vancomycin or metronidazole.
Time frame: Up to 28 days after treatment
The presence of skin contamination with C. difficile spores during and following treatment with fidaxomicin, vancomycin or metronidazole.
Time frame: Up to 28 days after treatment
2 secondary outcomes
C.difficile spore counts in the faeces of CDI patients before, during and after treatment with fidaxomicin, vancomycin or metronidazole.
Time frame: Up to 28 days after treatment
Total C. difficile spore counts from skin swab samples during and following treatment with fidaxomicin, vancomycin or metronidazole.
Time frame: Up to 28 days after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Individual participant dataSharing planned: Undecided
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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.
Mark H Wilcox study chair
Leeds Teaching Hospitals NHS Trust
Tim Planche principal investigator
St George's Healthcare NHS Trust
Philip Stanley principal investigator
Bradford Teaching Hospitals NHS Foundation Trust
3 sites 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, run by Professor Mark Wilcox at 3 sites in United Kingdom.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The presence of environmental contamination with C. difficile spores during and following treatment with fidaxomicin, vancomycin or metronidazole. (time frame: Up to 28 days after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2021.