Oral Vancomycin for Preventing Clostridium Difficile Recurrence

Rochester General Hospital

Status and phase: Terminated; Phase 4

Conditions: Clostridium Difficile Infection

Treatments: Drug: Oral Vancomycin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03200093

CIC 1745-B-17 Laguio-Vila

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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65 participants in 2 patient groups, including a placebo group

Oral vancomycin

Experimental group

Description:

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.

Treatment:

Drug: Oral Vancomycin

Placebo arm

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo