Clinical trial NCT02951702: Oral Vancomyin for Primary Clostridium Difficile Infection Prophylaxis in Patients Receiving High-Risk Antibiotics
Official title: Oral Vancomyin for Primary Clostridium Difficile Infection Prophylaxis in Patients Receiving High-Risk Antibiotics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Clostridium Difficile Infection
Prophylaxis
Vancomycin
Lead sponsor: St. Luke's Hospital, Chesterfield, Missouri
Sponsor class: OTHER
First posted: 2016-11-01
Enrollment: 51
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if oral vancomycin used as primary Clostridium difficile prophylaxis can reduce the incidence of this infection in high-risk patients.

Detailed description: Clostridium difficile infection is a common healthcare-associated infection and one that is associated with significant morbidity as well as a risk for mortality. Current practice throughout the United States is targeted at infection prevention measures such as hand washing and isolation. Despite these measures, incidence of Clostridium difficile infections continue to rise as some institutions, including our own. Recently, a study published in Clinical Infectious Diseases found oral vancomycin for secondary prophylaxis to reduce the incidence of recurrence. No studies to date have evaluated primary prophylaxis with oral vancomycin. This will be a single center, prospective study to evaluate oral vancomycin use as primary Clostridium difficile prophylaxis. Patients treated by infectious disease physicians will be identified as "high risk" and after pager notification the ID physician will have the option to start oral vancomycin 125 mg by mouth daily if they determine it to be appropriate. Risk factors include age older than 65 years, taking gastric acid suppression medication, and receiving select broad-spectrum antibiotics. Oral vancomycin will be continued until de-escalation of antibiotics or hospital discharge and patients will be evaluated for Clostridium difficile infection development from the current hospital admission up to 4 weeks following antibiotic discontinuation.

Eligibility criteria: Inclusion Criteria:

* "High-risk" patients defined as: age older than 65, on gastric acid suppression, and select antibiotics
* Gastric acid suppression includes proton pump inhibitors and histamine-2 receptor antagonists
* Selected antibiotics include fluoroquinolone (ciprofloxacin, levofloxacin), clindamycin, a 3rd or 4th generation cephalosporin, a broad-spectrum aminopenicillin (ampicillin-sulbactam, piperacillin-tazobactam), or a carbapenem

Exclusion Criteria:

* Failure to meet all three requirements for "high risk"
* Vancomycin allergy
* Active clostridium difficile infection prior to inclusion
* Prophylactic oral vancomycin prior to study inclusion (i.e. prolonged vancomycin taper)
* Receipt of medications that also treat Clostridium difficile (metronidazole, rifaximin, fidaxomicin)
* Pregnant or breastfeeding

Primary outcomes:
measure: Clostridium Difficile Infection Occurrence
timeFrame: Within 4 weeks from the completion of antibiotic treatment
Secondary outcomes:
measure: Time to Clostridium Difficile Infection Occurence
timeFrame: Within 4 weeks from completion of antibiotic treatment
measure: Clostridium Difficile Infection Severity
timeFrame: Within 4 weeks from completion of antibiotic treatment
Other outcomes:
Locations:
Study officials:
affiliation: St. Luke's Hospital
name: Ryan E Medas, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Van Hise NW, Bryant AM, Hennessey EK, Crannage AJ, Khoury JA, Manian FA. Efficacy of Oral Vancomycin in Preventing Recurrent Clostridium difficile Infection in Patients Treated With Systemic Antimicrobial Agents. Clin Infect Dis. 2016 Sep 1;63(5):651-3. doi: 10.1093/cid/ciw401. Epub 2016 Jun 17.
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