Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 73 of 530 for:    VANCOMYCIN

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

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.

Condition or disease Intervention/treatment Phase
Clostridium Difficile Infection Prophylaxis Vancomycin Drug: Vancomycin Oral Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Oral Vancomyin for Primary Clostridium Difficile Infection Prophylaxis in Patients Receiving High-Risk Antibiotics
Study Start Date : November 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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 Name: Oral vancomycin; vancomycin




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02951702


Sponsors and Collaborators
St. Luke's Hospital, Chesterfield, Missouri
Investigators
Layout table for investigator information
Principal Investigator: Ryan E Medas, PharmD St. Luke's Hospital
  Study Documents (Full-Text)

Documents provided by Ryan Medas, St. Luke's Hospital, Chesterfield, Missouri:

Publications:

Layout table for additonal information
Responsible Party: Ryan Medas, PGY2 Pharmacy Internal Medicine Resident, St. Luke's Hospital, Chesterfield, Missouri
ClinicalTrials.gov Identifier: NCT02951702     History of Changes
Other Study ID Numbers: 940920-2
First Posted: November 1, 2016    Key Record Dates
Results First Posted: December 27, 2017
Last Update Posted: December 27, 2017
Last Verified: November 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Vancomycin
Anti-Infective Agents