Oral Vancomycin for Preventing Clostridium Difficile Recurrence

Study Overview
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Brief Summary
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This study evaluates the role of oral vancomycin in the prevention of recurrent Clostridium difficile for hospitalized patients receiving systemic antibiotic therapy. Half of participants will receive oral vancomycin daily, while the other half will receive a placebo.

Detailed Description
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Clostridium difficile colitis is a significant cause of morbidity and mortality among hospitalized patients. Following the first episode, up to 15% of people experience recurrent disease. A major risk factor for recurrent disease is exposure to systemic antibiotics. Oral vancomycin given four times daily is one of the treatments for Clostridium difficile infection; it is not known if giving oral vancomycin at a lower dose such as once daily may help prevent recurrences. Oral vancomycin may be most helpful in preventing recurrences when given to patients at greatest risk of recurrent disease, such as when they are receiving systemic antibiotics. To evaluate this, the investigators propose comparing the rates of recurrent Clostridium difficile infection in patients who receive oral vancomycin with systemic antibiotics to when patients take systemic antibiotics alone.

Official Title
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Secondary Prophylaxis With Oral Vancomycin for Clostridium Difficile Recurrence: A Randomized Control Study

Conditions
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Clostridium Difficile Infection

Intervention / Treatment
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* Drug: Oral Vancomycin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years and older Any history of Clostridium difficile infection based on a positive Clostridium difficile stool test performed at a lab affiliated with Rochester Regional Health System or patient report A new in-patient admission, with an antibiotic treatment plan for greater than 48 hours Exclusion Criteria: Documented allergy and/or adverse drug reaction to vancomycin Pregnant Patients who are admitted with a current episode of Clostridium difficile infection Patients with total colectomy

Ages Eligible for Study
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Minimum Age: 18 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: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, placebo-controlled
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral vancomycin<br>Oral vancomycin solution 125 mg in 2.5 mL, combined with 2.5 ml Ora-Sweet solution, to total 5 mL. Taken by mouth once daily for: If the total duration of systemic antibiotics is less than or equal to 14 days, oral vancomycin will be taken for the duration of the systemic antibiotics plus three days. If the total duration of systemic antibiotics is greater than 14 days, oral vancomycin will be taken for the duration of the systemic antibiotics plus seven days. | Drug: Oral Vancomycin<br>* Oral vancomycin solution 125 mg in 2.5 mL combined with 2.5 mL Ora-Sweet. A total of 5 mL combined solution taken by mouth once daily.<br>* Other names: Study drug;|
| Placebo Comparator: Placebo arm<br>Ora-Sweet 5 mL Taken by mouth once daily for: If the total duration of systemic antibiotics is less than or equal to 14 days, placebo will be taken for the duration of the systemic antibiotics plus three days. If the total duration of systemic antibiotics is greater than 14 days, placebo will be taken for the duration of the systemic antibiotics plus seven days. | Drug: Placebo<br>* Ora-Sweet 5mL taken by mouth once daily.<br>* Other names: Study placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day recurrent Clostridium difficile infection | A positive Clostridium difficile stool test in the 30 days following completion of the systemic antibiotic treatment. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 90-day recurrent Clostridium difficile infection | A positive Clostridium difficile stool test in the 90 days following completion of the systemic antibiotic treatment. | 90 days | 
| 30-day hospital re-admission | All-cause re-admission to any hospital | 30 days | 
| 30-day mortality | All-cause mortality in the 30 days following completion of the systemic antibiotics | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clostridium difficile, C diff, Oral Vancomycin, Prophylaxis