Oral Vancomyin for Primary Clostridium Difficile Infection Prophylaxis in Patients Receiving High-Risk Antibiotics

Study Overview
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Brief Summary
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The purpose of this study is to determine if oral vancomycin used as primary Clostridium difficile prophylaxis can reduce the incidence of this infection in high-risk patients.

Detailed Description
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Clostridium difficile infection is a common healthcare-associated infection and one that is associated with significant morbidity as well as a risk for mortality. Current practice throughout the United States is targeted at infection prevention measures such as hand washing and isolation. Despite these measures, incidence of Clostridium difficile infections continue to rise as some institutions, including our own. Recently, a study published in Clinical Infectious Diseases found oral vancomycin for secondary prophylaxis to reduce the incidence of recurrence. No studies to date have evaluated primary prophylaxis with oral vancomycin. This will be a single center, prospective study to evaluate oral vancomycin use as primary Clostridium difficile prophylaxis. Patients treated by infectious disease physicians will be identified as high risk and after pager notification the ID physician will have the option to start oral vancomycin 125 mg by mouth daily if they determine it to be appropriate. Risk factors include age older than 65 years, taking gastric acid suppression medication, and receiving select broad-spectrum antibiotics. Oral vancomycin will be continued until de-escalation of antibiotics or hospital discharge and patients will be evaluated for Clostridium difficile infection development from the current hospital admission up to 4 weeks following antibiotic discontinuation.

Official Title
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Oral Vancomyin for Primary Clostridium Difficile Infection Prophylaxis in Patients Receiving High-Risk Antibiotics

Conditions
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Clostridium Difficile Infection, Prophylaxis, Vancomycin

Intervention / Treatment
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* Drug: Vancomycin Oral


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: High-risk patients defined as: age older than 65, on gastric acid suppression, and select antibiotics Gastric acid suppression includes proton pump inhibitors and histamine-2 receptor antagonists Selected antibiotics include fluoroquinolone (ciprofloxacin, levofloxacin), clindamycin, a 3rd or 4th generation cephalosporin, a broad-spectrum aminopenicillin (ampicillin-sulbactam, piperacillin-tazobactam), or a carbapenem Exclusion Criteria: Failure to meet all three requirements for high risk Vancomycin allergy Active clostridium difficile infection prior to inclusion Prophylactic oral vancomycin prior to study inclusion (i.e. prolonged vancomycin taper) Receipt of medications that also treat Clostridium difficile (metronidazole, rifaximin, fidaxomicin) Pregnant or breastfeeding

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>This will be the historical arm that has not received oral vancomycin but match criteria for high risk | |
| Experimental: Vancomycin Oral<br>This arm will receive oral vancomycin 125 mg daily if high risk and determined to be appropriate by an ID physician Intervention type: drug, vancomycin 125 mg daily | Drug: Vancomycin Oral<br>* This arm will receive oral vancomycin 125 mg daily if high risk and determined to be appropriate by an ID physician<br>* Other names: Oral vancomycin; vancomycin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clostridium Difficile Infection Occurrence | The incidence of clostridium difficile infection as detected for GDH/toxin positive or PCR if the GDH/toxin is equivocal. | Within 4 weeks from the completion of antibiotic treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Clostridium Difficile Infection Occurence | This is the time from the start of antibiotics to the diagnosis of clostridium difficile. | Within 4 weeks from completion of antibiotic treatment | 
| Clostridium Difficile Infection Severity | Severity as defined by the IDSA/SHEA guidelines (mild to moderate, defined as white-cell count less than 15,000 cells/µL or increase in serum creatinine (SCr) by <1.5 times the baseline; severe, defined as white-cell count greater than 15,000 cells/µL or increase in SCr by >1.5 times the baseline; and fulminant, defined as the criteria above for severe with shock, hypotension, ileus, or megacolon) | Within 4 weeks from completion of antibiotic treatment |