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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
65
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.
Ora-Sweet 5mL taken by mouth once daily.
Rochester General Hospital
Rochester, New York, United States
30-day recurrent Clostridium difficile infection
A positive Clostridium difficile stool test in the 30 days following completion of the systemic antibiotic treatment.
Time frame: 30 days
90-day recurrent Clostridium difficile infection
A positive Clostridium difficile stool test in the 90 days following completion of the systemic antibiotic treatment.
Time frame: 90 days
30-day hospital re-admission
All-cause re-admission to any hospital
Time frame: 30 days
30-day mortality
All-cause mortality in the 30 days following completion of the systemic antibiotics
Time frame: 30 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.