A Phase 4 interventional study of Vancomycin and Placebo in Clostridium Difficile Infection, sponsored by William Beaumont Hospitals. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-13.
Sponsored by William Beaumont Hospitals · Phase 4, Interventional, and Prevention
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.
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.
251 studies on the registry are indexed under Clostridium Infections; 51 are open to participants now.
This study's enrollment of 1,294 is above the median of 64 across 185 interventional studies indexed under Clostridium Infections.
Browse Clostridium Infections studies →William Beaumont Hospitals is the lead sponsor of 111 studies on the registry; none are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 30 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Placebo
Vancomycin 125 mg by mouth every 6 hours
Drug: Vancomycin
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.
Time frame: 12 weeks after treatment
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.
Time frame: 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.
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.
Number of participants who remained colonized with C. difficile after treatment. This outcome is only applicable to the two randomized arms.
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.
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.
Time frame: 12 weeks after antibiotics
Participants were recruited based on initiation of high-risk antibiotic treatment for a minimum expedited duration of three days, between December 15, 2016 and June 30, 2023. The first participant was enrolled on December 19, 2016 and the last participant was enrolled June 28, 2023.
| Milestone | Placebo | Vancomycin | Screened Negative for C. Difficile Colonization |
|---|---|---|---|
| Started | 14 | 13 | 647 |
| Completed | 11 | 8 | 647 |
| Not completed | 3 | 5 | 0 |
| Withdrew: Lost to follow-up | 1 | 1 | 0 |
| Withdrew: Death | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 2 | 3 | 0 |
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.
| Participants | Placebo | Vancomycin |
|---|---|---|
| The Incidence of CDI in Inpatients Receiving Vancomycin Prophylaxis vs. Placebo Who Are on High-risk Antibiotics and Are Colonized With Toxigenic C. Difficile. | 0 | 0 |
Number of randomized participants with mild, moderate, severe or fulminant disease after treatment. This outcome is only applicable to the two randomized arms.
| Participants | Placebo | Vancomycin |
|---|---|---|
| mild | 0 | 0 |
| moderate | 0 | 0 |
| severe | 0 | 0 |
| fulminant | 0 | 0 |
| no disease | 11 | 8 |
Number of participants who developed C difficile infection after treatment. This outcome is only applicable to the two randomized arms.
| Participants | Placebo | Vancomycin |
|---|---|---|
| The Outcome of CDI in Patients Receiving Vancomycin Prophylaxis vs. Placebo. | 0 | 0 |
Number of participants who remained colonized with C. difficile after treatment. This outcome is only applicable to the two randomized arms.
| Participants | Placebo | Vancomycin |
|---|---|---|
| The Prevalence of Toxigenic C. Difficile Colonization Among the Inpatient Population Treated With High-risk Antibiotics Based on C. Difficile PCR. | 5 | 5 |
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.
| Participants | Screened Negative for C. Difficile Colonization |
|---|---|
| The Incidence of CDI in Patients Initiated on High Risk Antibiotics Who Are Not Colonized With Toxigenic C. Difficile. | 4 |
Collected over 12 weeks following completion of antibiotic treatment (an average of 13 weeks total). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/14 (0%) | 4/14 (28.6%) | 8/14 (57.1%) |
| Vancomycin | 1/13 (7.7%) | 4/13 (30.8%) | 8/13 (61.5%) |
| Event | Placebo | Vancomycin |
|---|---|---|
| Acute hypoxic respiratory failureRespiratory, thoracic and mediastinal disorders | 1/14 | 1/13 |
| Acute hypoxemic respiratory failureRespiratory, thoracic and mediastinal disorders | 0/14 | 1/13 |
| Gastrointestinal bleedGastrointestinal disorders | 0/14 | 1/13 |
| Bloody diarrheaGastrointestinal disorders | 0/14 | 1/13 |
| Chronic obstructive pulmonary disease exacerbationRespiratory, thoracic and mediastinal disorders | 1/14 | 0/13 |
| Congestive heart failureCardiac disorders | 1/14 | 0/13 |
| Shortness of breathRespiratory, thoracic and mediastinal disorders | 1/14 | 0/13 |
| Hyponatremia (present at baseline)Metabolism and nutrition disorders | 1/14 | 0/13 |
| Febrile neutropeniaBlood and lymphatic system disorders | 1/14 | 0/13 |
| Event | Placebo | Vancomycin |
|---|---|---|
| Bruise, left breastInjury, poisoning and procedural complications | 0/14 | 1/13 |
| DiarrheaGastrointestinal disorders | 1/14 | 1/13 |
| Fall, related to previous issue with right kneeInjury, poisoning and procedural complications | 0/14 | 1/13 |
| Fall, with participant hitting head while anticoagulatedInjury, poisoning and procedural complications | 0/14 | 1/13 |
| Urinary tract infectionInfections and infestations | 0/14 | 1/13 |
| ConstipationGastrointestinal disorders | 0/14 | 1/13 |
| Phlebitis/cellulitisVascular disorders | 0/14 | 1/13 |
| Infected tooth, required extraction and antibiotic prescriptionInfections and infestations | 0/14 | 1/13 |
| Abdominal pain due to constipationGastrointestinal disorders | 1/14 | 0/13 |
| Hemorrhagic ovarian cystReproductive system and breast disorders | 1/14 | 0/13 |
| Age, Continuous(years) | Placebo | Vancomycin | Screened Negative for C. Difficile Colonization | Total |
|---|---|---|---|---|
| Mean | 63.8 ± 15.3 | 68.6 ± 15.5 | — | 68.44 ± 17.57 |
| Sex: Female, Male(Participants) | Placebo | Vancomycin | Screened Negative for C. Difficile Colonization | Total |
|---|---|---|---|---|
| Female | 8 | 6 | — | 14 |
| Male | 6 | 7 | — | 13 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | Vancomycin | Screened Negative for C. Difficile Colonization | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | — | 0 |
| Not Hispanic or Latino | 12 | 13 | — | 25 |
| Unknown or Not Reported | 2 | 0 | — | 2 |
| Race (NIH/OMB)(Participants) | Placebo | Vancomycin | Screened Negative for C. Difficile Colonization | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | — | 0 |
| Asian | 0 | 0 | — | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | — | 0 |
| Black or African American | 0 | 1 | — | 1 |
| White | 13 | 12 | — | 25 |
| More than one race | 0 | 0 | — | 0 |
| Unknown or Not Reported | 1 | 0 | — | 1 |
| Region of Enrollment(participants) | Placebo | Vancomycin | Screened Negative for C. Difficile Colonization | Total |
|---|---|---|---|---|
| United States | 14 | 13 | 647 | 27 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Vancomycin