Oral Vancomycin for Preventing Clostridium Difficile Recurrence

Phase 4

Terminated

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Oral vancomycin	Oral Vancomycin	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: 1. 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. 2. 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.
Placebo arm	Placebo	Ora-Sweet 5 mL Taken by mouth once daily for: 1. 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. 2. 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.

Primary Outcome Measures

Name	Time	Method
30-day recurrent Clostridium difficile infection	30 days	A positive Clostridium difficile stool test in the 30 days following completion of the systemic antibiotic treatment.

Secondary Outcome Measures

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

Locations (1): Rochester General Hospital
🇺🇸
Rochester, New York, United States

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