Oral Vancomyin for Primary Clostridium Difficile Infection Prophylaxis in Patients Receiving High-Risk Antibiotics

St. Luke's Hospital, Chesterfield, Missouri

Status and phase: Completed; Phase 4

Conditions: Vancomycin; Prophylaxis; Clostridium Difficile Infection

Treatments: Drug: Vancomycin Oral

Study type: Interventional

Funder types: Other

Identifiers

NCT02951702

940920-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

Control

No Intervention group

Description:

This will be the historical arm that has not received oral vancomycin but match criteria for "high risk"

Vancomycin Oral

Experimental group

Description:

This arm will receive oral vancomycin 125 mg daily if "high risk" and determined to be appropriate by an ID physician Intervention type: drug, vancomycin 125 mg daily

Treatment:

Drug: Vancomycin Oral