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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| vancomycin | Active Comparator | Vancomycin 125 mg by mouth every 6 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vancomycin | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks after treatment |
| The Outcome of CDI in Patients Receiving Vancomycin Prophylaxis vs. Placebo. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Sims, MD PhD | Beaumont Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| William Beaumont Hospital | Dearborn | Michigan | 48124 | United States | ||
| William Beaumont Hospital |
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Of 1294 participants consented, 728 provided stool samples. 81 met inclusion criteria of culture of stool sample verifying presence of toxigenic C. difficile, and of these 81, 27 consented to randomization to treatment with vancomycin or placebo. These 27 participants are listed in the randomized participant flow below (placebo group or vancomycin group). 647 participants who screened negative and who were not randomized were available for analysis for secondary outcome 5.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Patients who screened positive for the presence of C. difficile colonization were randomized to one of two groups: The Placebo group received a placebo liquid 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. Placebo |
| FG001 | Vancomycin | Patients who screened positive for the presence of C. difficile colonization were randomized to one of two groups: the Study group received Vancomycin 125 mg by mouth every 6 hours Vancomycin |
| FG002 | Screened Negative for C. Difficile Colonization | Patients who screened negative at enrollment for the presence of C. difficile were not eligible for the randomized portion of the trial, but were available analysis of secondary outcome 5. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Patients who screened positive for the presence of C. difficile colonization were randomized to one of two groups: The Placebo group received a placebo liquid 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. Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Data not available for 3 patients lost to follow-up/withdrawn in placebo arm and 4 patients lost to follow-up/withdrawn and 1 death in vancomycin arm. | Posted | Count of Participants | Participants | 12 weeks after treatment |
|
12 weeks following completion of antibiotic treatment (an average of 13 weeks total)
Per protocol, not all adverse events were documented. Participants were queried about any current abdominal pain, nausea, vomiting, abdominal bloating, diarrhea, fever; any signs of adverse reaction to the study medication. Adverse events were queried at follow up visits and by participant self-report if it was between follow-up calls.
Adverse events were not collected for participants who screened negative for C. difficile infection (non-randomized participants); therefore arm not included.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Patients who screened positive for the presence of C. difficile colonization were randomized to one of two groups: The Placebo group received a placebo liquid 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. Placebo |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute hypoxic respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain due to constipation | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maureen Cooney | Beaumont Hospitals | 248 551-0099 | maureen.cooney@corewellhealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 20, 2019 | Mar 25, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 20, 2022 | Aug 2, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
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|
Number of participants who developed C difficile infection after treatment. This outcome is only applicable to the two randomized arms. |
| 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. | 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. | 12 weeks after antibiotics |
| Royal Oak |
| Michigan |
| 48073 |
| United States |
| William Beaumont Hospital | Troy | Michigan | 48085 | United States |
| Withdrawal by Subject |
|
| BG001 |
| Vancomycin |
Patients who screened positive for the presence of C. difficile colonization were randomized to one of two groups: the Study group received Vancomycin 125 mg by mouth every 6 hours Vancomycin |
| BG002 | Screened Negative for C. Difficile Colonization | Patients who screened negative at enrollment for the presence of C. difficile were not eligible for the randomized portion of the trial, but were available analysis of secondary outcome 5. |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment. | Count of Participants | Participants |
|
| Race (NIH/OMB) | 647 patients who screened negative for C. difficile infection and were not enrolled in the randomized portion of the study did not have any baseline characteristics collected except region of enrollment. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Vancomycin | Patients who screened positive for the presence of C. difficile colonization were randomized to one of two groups: the Study group received Vancomycin 125 mg by mouth every 6 hours Vancomycin |
|
|
| Secondary | 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. | Data not available for 3 patients withdrawn/lost to follow-up in placebo arm and 4 patients withdrawn/lost to follow-up and 1 death in vancomycin arm. | Posted | Count of Participants | Participants | 12 weeks after treatment |
|
|
|
| Secondary | 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. | Data not available for 3 patients lost to follow-up/withdrawn in placebo arm and 4 patients lost to follow-up/withdrawn and 1 death in vancomycin arm. | Posted | Count of Participants | Participants | 12 weeks after treatment |
|
|
|
| Secondary | 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. | Data not available for 3 patients withdrawn/lost to follow-up in the placebo arm, and 4 patients withdrawn/lost to follow-up plus one death in the vancomycin arm. One patient in the placebo arm did not give a stool sample. | Posted | Count of Participants | Participants | 12 weeks after treatment |
|
|
|
| Secondary | 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. | Patients were originally screened for C. difficile colonization prior to randomization. This population represents the 647 participants who initially screened negative for C. difficile colonization and were not placed into the randomized portion of the study, but were assessed at 12 weeks for C. difficile infection. This outcome is not applicable to the colonized, randomized participants. | Posted | Count of Participants | Participants | 12 weeks after antibiotics |
|
|
|
| 0 |
| 14 |
| 4 |
| 14 |
| 8 |
| 14 |
| EG001 | Vancomycin | Patients who screened positive for the presence of C. difficile colonization were randomized to one of two groups: the Study group received Vancomycin 125 mg by mouth every 6 hours Vancomycin | 1 | 13 | 4 | 13 | 8 | 13 |
| Acute hypoxemic respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Chronic obstructive pulmonary disease exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Congestive heart failure | Cardiac disorders | Systematic Assessment |
|
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hyponatremia (present at baseline) | Metabolism and nutrition disorders | Systematic Assessment |
|
| Gastrointestinal bleed | Gastrointestinal disorders | Systematic Assessment |
|
| Bloody diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Bruise, left breast | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Fall, related to previous issue with right knee | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hemorrhagic ovarian cyst | Reproductive system and breast disorders | Systematic Assessment |
|
| Left lower quadrant tenderness | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Fall, with participant hitting head while anticoagulated | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Phlebitis/cellulitis | Vascular disorders | Systematic Assessment |
|
| Purulent drainage of left knee incision | Infections and infestations | Systematic Assessment |
|
| Infected tooth, required extraction and antibiotic prescription | Infections and infestations | Systematic Assessment |
|
| Chills | General disorders | Systematic Assessment |
|
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| D000602 |
| Amino Acids, Peptides, and Proteins |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| severe |
|
| fulminant |
|
| no disease |
|