Clostridium Difficile Infection
Conditions
Keywords
Clostridium difficile, C diff, Oral Vancomycin, Prophylaxis
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.
Interventions
DRUGOral 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.
DRUGPlacebo
Ora-Sweet 5mL taken by mouth once daily.
Sponsors
Rochester General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, 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.
Intervention model description
Randomized, placebo-controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Vancomycin resistance isolated | 90 days | Isolation of a vancomycin-resistant bacteria during an infectious workup, if clinically indicated |
| 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. |
Countries
United States
Outcome results
None listed