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

November 30, 2017 updated by: Ryan Medas, St. Luke's Hospital, Chesterfield, Missouri
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
This will be the historical arm that has not received oral vancomycin but match criteria for "high risk"
EXPERIMENTAL: Vancomycin Oral
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
Drug: Vancomycin Oral
This arm will receive oral vancomycin 125 mg daily if "high risk" and determined to be appropriate by an ID physician
Other Names:
  • Oral vancomycin; vancomycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clostridium Difficile Infection Occurrence
Time Frame: Within 4 weeks from the completion of antibiotic treatment
The incidence of clostridium difficile infection as detected for GDH/toxin positive or PCR if the GDH/toxin is equivocal.
Within 4 weeks from the completion of antibiotic treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Clostridium Difficile Infection Occurence
Time Frame: Within 4 weeks from completion of antibiotic treatment
This is the time from the start of antibiotics to the diagnosis of clostridium difficile.
Within 4 weeks from completion of antibiotic treatment
Clostridium Difficile Infection Severity
Time Frame: Within 4 weeks from completion of antibiotic treatment
Severity as defined by the IDSA/SHEA guidelines (mild to moderate, defined as white-cell count less than 15,000 cells/µL or increase in serum creatinine (SCr) by <1.5 times the baseline; severe, defined as white-cell count greater than 15,000 cells/µL or increase in SCr by >1.5 times the baseline; and fulminant, defined as the criteria above for severe with shock, hypotension, ileus, or megacolon)
Within 4 weeks from completion of antibiotic treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Luke's Hospital, Chesterfield, Missouri

Investigators

  • Principal Investigator: Ryan E Medas, PharmD, St. Luke's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (ACTUAL)

May 1, 2017

Study Completion (ACTUAL)

July 1, 2017

Study Registration Dates

First Submitted

October 30, 2016

First Submitted That Met QC Criteria

October 30, 2016

First Posted (ESTIMATE)

November 1, 2016

Study Record Updates

Last Update Posted (ACTUAL)

December 27, 2017

Last Update Submitted That Met QC Criteria

November 30, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 940920-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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