Clinical trial NCT03200093: Oral Vancomycin for Preventing Clostridium Difficile Recurrence
Official title: Secondary Prophylaxis With Oral Vancomycin for Clostridium Difficile Recurrence: A Randomized Control Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Clostridium Difficile Infection
Keywords: Clostridium difficile
C diff
Oral Vancomycin
Prophylaxis
Lead sponsor: Rochester General Hospital
Sponsor class: OTHER
First posted: 2017-06-27
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, placebo-controlled
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: 30-day recurrent Clostridium difficile infection
timeFrame: 30 days
Secondary outcomes:
measure: 90-day recurrent Clostridium difficile infection
timeFrame: 90 days
measure: 30-day hospital re-admission
timeFrame: 30 days
measure: 30-day mortality
timeFrame: 30 days
Other outcomes:
measure: Impact of duration of systemic antibiotics on Clostridium difficile recurrence
timeFrame: 90 days
measure: Impact of acid-suppressing medications on Clostridium difficile recurrence
timeFrame: 90 days
measure: Impact of age on Clostridium difficile recurrence
timeFrame: 90 days
measure: Impact of systemic antibiotic class on Clostridium difficile recurrence
timeFrame: 90 days
measure: Vancomycin resistance isolated
timeFrame: 90 days
Locations:
city: Rochester
country: United States
facility: Rochester General Hospital
state: New York
Study officials:
affiliation: Rochester General Hospital
name: Maryrose R Laguio-Vila, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Carignan A, Poulin S, Martin P, Labbe AC, Valiquette L, Al-Bachari H, Montpetit LP, Pepin J. Efficacy of Secondary Prophylaxis With Vancomycin for Preventing Recurrent Clostridium difficile Infections. Am J Gastroenterol. 2016 Dec;111(12):1834-1840. doi: 10.1038/ajg.2016.417. Epub 2016 Sep 13.
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