Clostridium Difficile InfectionPhase 4StoP CDINCT02996487
Screening to Prophylax Against Clostridium Difficile Infection -
A Phase 4 study testing Vancomycin in people with Clostridium Difficile Infection, run by Corewell Health East at 3 sites in United States.
Trial summary
The goal of this study is to evaluate whether using vancomycin orally can prevent CDI in patients who are colonized with C. difficile who are admitted to the hospital and need antibiotics for another infection. 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?
- Vancomycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,294 participants
- Where
- 3 sitesUnited States
- Study dates
- 19 Dec 2016to 28 Jun 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Expected duration of admission sufficient to complete screening and enrollment
- Age ≥18
- Able to give informed consent
- Initiated on one of the following antibiotics within the prior 72 hours with an expected duration of at least 72 hours from enrollment: clindamycin, ampicillin, ampicillin/sulbactam, amoxicillin, amoxicillin/clavulanate, moxifloxacin, levofloxacin, piperacillin/tazobactam, or any cephalosporin
- Maximum expected duration of antibiotics 8 weeks
- Able to take oral study medications
- Able to provide a stool sample during hospitalization or within 3 days of discharge
- Reasonably expected to be able to complete follow up
Who cannot join
- Chron's disease, ulcerative colitis, celiac disease, or other chronic diarrheal illness
- CDI within prior 90 days
- Currently on metronidazole, oral vancomycin, rifaximin, fidaxomicin, or any other antibiotic active against C. difficile
- Current diarrhea
- Current ileostomy, colostomy or other form of surgically disconnected gut such that oral therapy would not be expected to reach the entire lumen of the gut
- Pregnancy or breast feeding (determined prior to randomization)
Show all 11Show fewer
- Travel to an area of endemic diarrheal illness within the last 30 days
- Life expectancy of less than 60 days
- Known allergy to vancomycin
- Participation with other research trials that could impact the results of this trial within the last 30 days
- Previously enrolled in this study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
William Beaumont Hospital
Dearborn, Michigan, 48124
William Beaumont Hospital
Royal Oak, Michigan, 48073
William Beaumont Hospital
Troy, Michigan, 48085
About this study
Official title: Screening to Prophylax Against Clostridium Difficile Infection
The goal of this study is to evaluate whether using vancomycin orally can prevent CDI in patients who are colonized with C. difficile who are admitted to the hospital and need antibiotics for another infection.
Read the detailed description
Screening to Prophylax against CDI (SToP CDI) is a prospective, single-center, double-blinded, randomized, placebo-controlled study of the effectiveness of vancomycin vs. placebo for preventing CDI in patients colonized with toxigenic C. difficile and receiving high-risk antibiotics. The investigators plan to screen 2500 patients to randomize 200.
Consented patients will have a stool sample collected and tested for presence of toxigenic C. difficile by polymerase chain reaction (PCR) test. Patients who test negative will simply be followed for development, severity and outcome of CDI. Patients who test positive (are colonized with C. difficile) will be randomized to one of two arms:
Arm 1: Patients receive 125 mg vancomycin by mouth (PO) every 6 hours as prophylaxis against C. difficile for the duration of their antibiotic treatment +3 days.
Arm 2: Patients receive placebo by mouth (PO) every 6 hours for the duration of their antibiotic treatment +3 days.
- Conditions
- Clostridium Difficile Infection
- Being tested
- Vancomycin, Placebo
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VancomycinDrug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo every 6 hours. A placebo will look like the drug being studied, but have no active ingredients, in this case it will be fruit punch with vitamins added to mimic the taste of vancomycin. Receives: Other: Placebo |
| vancomycin | Active comparator | Vancomycin 125 mg by mouth every 6 hours Receives: Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Incidence of CDI in Inpatients Receiving Vancomycin Prophylaxis vs. Placebo Who Are on High-risk Antibiotics and Are Colonized With Toxigenic C. Difficile.
Number of participants with CDI in this subgroup of patients as assessed by clinical presentation, polymerase chain reaction (PCR) testing of stool, and EIA test for production of toxins. Patients are considered to have CDI if they have a positive PCR test, a positive toxin enzyme immunoassay (EIA) test, and clinical symptoms compatible with CDI. This outcome is only applicable to the two randomized arms.
Measured: 12 weeks after treatment
Secondary outcomes (4)
The Severity of CDI in Patients Receiving Vancomycin Prophylaxis vs. Placebo.
Number of randomized participants with mild, moderate, severe or fulminant disease after treatment. This outcome is only applicable to the two randomized arms.
Measured: 12 weeks after treatment
The Outcome of CDI in Patients Receiving Vancomycin Prophylaxis vs. Placebo.
Number of participants who developed C difficile infection after treatment. This outcome is only applicable to the two randomized arms.
Measured: 12 weeks after treatment
The Prevalence of Toxigenic C. Difficile Colonization Among the Inpatient Population Treated With High-risk Antibiotics Based on C. Difficile PCR.
Number of participants who remained colonized with C. difficile after treatment. This outcome is only applicable to the two randomized arms.
Measured: 12 weeks after treatment
The Incidence of CDI in Patients Initiated on High Risk Antibiotics Who Are Not Colonized With Toxigenic C. Difficile.
Number of participants who developed CDI in this subgroup of patients as assessed by clinical presentation and PCR testing of stool. Patients are considered to have CDI if they have a positive PCR test and clinical symptoms compatible with CDI.
Measured: 12 weeks after antibiotics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study start19 Dec 2016
- Primary completion28 Jun 2023
- Study completion28 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Sims, MD, PhD, Corewell Health East
- Investigators
- Matthew Sims, MD PhD, Principal investigator, Beaumont Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996487
- Sponsor's protocol ID
- 2016-254
- Acronym
- StoP CDI
- Status last verified
- Jul 2024
- First submitted
- 17 Nov 2016
- Last updated
- 13 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening to Prophylax Against Clostridium Difficile Infection
- ClinicalTrials.gov ID
- NCT02996487
- Acronym / sponsor ID
- StoP CDI / 2016-254
- Conditions
- Clostridium Difficile Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,294 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- 19 Dec 2016 (actual)
- Primary completion
- 28 Jun 2023 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 19 Dec 2016 (estimated)
- Results
- Posted 13 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to evaluate whether using vancomycin orally can prevent CDI in patients who are colonized with C. difficile who are admitted to the hospital and need antibiotics for another infection.
Detailed description
Screening to Prophylax against CDI (SToP CDI) is a prospective, single-center, double-blinded, randomized, placebo-controlled study of the effectiveness of vancomycin vs. placebo for preventing CDI in patients colonized with toxigenic C. difficile and receiving high-risk antibiotics. The investigators plan to screen 2500 patients to randomize 200.
Consented patients will have a stool sample collected and tested for presence of toxigenic C. difficile by polymerase chain reaction (PCR) test. Patients who test negative will simply be followed for development, severity and outcome of CDI. Patients who test positive (are colonized with C. difficile) will be randomized to one of two arms:
Arm 1: Patients receive 125 mg vancomycin by mouth (PO) every 6 hours as prophylaxis against C. difficile for the duration of their antibiotic treatment +3 days.
Arm 2: Patients receive placebo by mouth (PO) every 6 hours for the duration of their antibiotic treatment +3 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboPlacebo every 6 hours. A placebo will look like the drug being studied, but have no active ingredients, in this case it will be fruit punch with vitamins added to mimic the taste of vancomycin. |
| vancomycin | Active comparator | Drug: VancomycinVancomycin 125 mg by mouth every 6 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Expected duration of admission sufficient to complete screening and enrollment
- Age ≥18
- Able to give informed consent
- Initiated on one of the following antibiotics within the prior 72 hours with an expected duration of at least 72 hours from enrollment: clindamycin, ampicillin, ampicillin/sulbactam, amoxicillin, amoxicillin/clavulanate, moxifloxacin, levofloxacin, piperacillin/tazobactam, or any cephalosporin
- Maximum expected duration of antibiotics 8 weeks
Key exclusion criteria (11 listed)
- Chron's disease, ulcerative colitis, celiac disease, or other chronic diarrheal illness
- CDI within prior 90 days
- Currently on metronidazole, oral vancomycin, rifaximin, fidaxomicin, or any other antibiotic active against C. difficile
- Current diarrhea
- Current ileostomy, colostomy or other form of surgically disconnected gut such that oral therapy would not be expected to reach the entire lumen of the gut
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 |
|---|---|---|
| Vancomycin | Drug | vancomycin |
| Placebo | Other | Placebo |
Primary outcome
The Incidence of CDI in Inpatients Receiving Vancomycin Prophylaxis vs. Placebo Who Are on High-risk Antibiotics and Are Colonized With Toxigenic C. Difficile.
Time frame: 12 weeks after treatment
Number of participants with CDI in this subgroup of patients as assessed by clinical presentation, polymerase chain reaction (PCR) testing of stool, and EIA test for production of toxins. Patients are considered to have CDI if they have a positive PCR test, a positive toxin enzyme immunoassay (EIA) test, and clinical symptoms compatible with CDI. This outcome is only applicable to the two randomized arms.
4 secondary outcomes
The Severity of CDI in Patients Receiving Vancomycin Prophylaxis vs. Placebo.
Time frame: 12 weeks after treatment
The Outcome of CDI in Patients Receiving Vancomycin Prophylaxis vs. Placebo.
Time frame: 12 weeks after treatment
The Prevalence of Toxigenic C. Difficile Colonization Among the Inpatient Population Treated With High-risk Antibiotics Based on C. Difficile PCR.
Time frame: 12 weeks after treatment
The Incidence of CDI in Patients Initiated on High Risk Antibiotics Who Are Not Colonized With Toxigenic C. Difficile.
Time frame: 12 weeks after antibiotics
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Matthew Sims, MD PhD principal investigator
Beaumont Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vancomycin in people with Clostridium Difficile Infection, run by Corewell Health East at 3 sites 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 8 inclusion and 11 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 13 Aug 2024. 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 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Incidence of CDI in Inpatients Receiving Vancomycin Prophylaxis vs. Placebo Who Are on High-risk Antibiotics and Are Colonized With Toxigenic C. Difficile. (time frame: 12 weeks after treatment). 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 13 Aug 2024.