Oral Vancomycin for Preventing Clostridium Difficile Recurrence

Sponsor

Rochester General Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT03200093

Collaborator

(none)

Enrollment

Location

Arms

46.5

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Clostridium Difficile Infection	Drug: Oral Vancomycin Drug: Placebo	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

65 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized, placebo-controlledRandomized, placebo-controlled

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

After enrollment, study pharmacists will randomize the participants to receive either oral vancomycin or placebo. Participants, care providers, investigators, and outcomes assessors will be masked.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jun 8, 2017

Actual Primary Completion Date :

Apr 22, 2021

Actual Study Completion Date :

Apr 22, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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: 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 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. Other Names: Study drug
Placebo Comparator: Placebo arm 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 Ora-Sweet 5mL taken by mouth once daily. Other Names: Study placebo

Arm

Intervention/Treatment

Experimental: 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: 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

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.

Other Names:

Study drug

Placebo Comparator: Placebo arm

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

Ora-Sweet 5mL taken by mouth once daily.

Other Names:

Study placebo

Outcome Measures

Primary Outcome Measures

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

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
30-day mortality [30 days]
All-cause mortality in the 30 days following completion of the systemic antibiotics

Other Outcome Measures

Impact of duration of systemic antibiotics on Clostridium difficile recurrence [90 days]
Comparing the frequency of a positive Clostridium difficile stool test in the 90 days following completion of systemic antibiotics, when the duration of systemic antibiotics was less than or equal to 14 days compared to longer durations.
Impact of acid-suppressing medications on Clostridium difficile recurrence [90 days]
Comparing the frequency of a positive Clostridium difficile stool test in the 90 days following completion of systemic antibiotics, when the participant was receiving acid-suppressing medications compared to those on none.
Impact of age on Clostridium difficile recurrence [90 days]
Comparing the frequency of a positive Clostridium difficile stool test in the 90 days following completion of systemic antibiotics, when the participant was older than 65 years of age compared to younger.
Impact of systemic antibiotic class on Clostridium difficile recurrence [90 days]
Comparing the frequency of a positive Clostridium difficile stool test in the 90 days following completion of systemic antibiotics, when the participant was receiving systemic antibiotics considered "high risk" for Clostridium difficile compared to those taking "low risk" antibiotics.
Vancomycin resistance isolated [90 days]
Isolation of a vancomycin-resistant bacteria during an infectious workup, if clinically indicated

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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