Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02951702
Recruitment Status : Completed
First Posted : November 1, 2016
Results First Posted : December 27, 2017
Last Update Posted : December 27, 2017
Sponsor:
Information provided by (Responsible Party):
Ryan Medas, St. Luke's Hospital, Chesterfield, Missouri

Tracking Information
First Submitted Date  ICMJE October 30, 2016
First Posted Date  ICMJE November 1, 2016
Results First Submitted Date  ICMJE October 3, 2017
Results First Posted Date  ICMJE December 27, 2017
Last Update Posted Date December 27, 2017
Study Start Date  ICMJE November 2016
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 30, 2016)
Clostridium Difficile Infection Occurrence [ Time Frame: Within 4 weeks from the completion of antibiotic treatment ]
Change History Complete list of historical versions of study NCT02951702 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2017)
  • 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.
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2016)
  • Time to Clostridium Difficile Infection Occurence [ Time Frame: 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Vancomyin for Primary Clostridium Difficile Infection Prophylaxis in Patients Receiving High-Risk Antibiotics
Official Title  ICMJE Oral Vancomyin for Primary Clostridium Difficile Infection Prophylaxis in Patients Receiving High-Risk Antibiotics
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Clostridium Difficile Infection
  • Prophylaxis
  • Vancomycin
Intervention  ICMJE 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 Name: Oral vancomycin; vancomycin
Study Arms  ICMJE
  • 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
    Intervention: Drug: Vancomycin Oral
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2017)
51
Original Estimated Enrollment  ICMJE
 (submitted: October 30, 2016)
200
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02951702
Other Study ID Numbers  ICMJE 940920-2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ryan Medas, St. Luke's Hospital, Chesterfield, Missouri
Study Sponsor  ICMJE St. Luke's Hospital, Chesterfield, Missouri
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ryan E Medas, PharmD St. Luke's Hospital
PRS Account St. Luke's Hospital, Chesterfield, Missouri
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP