Status:
TERMINATED
Efficacy of Metronidazole Prophylaxis Against Clostridium Difficile-Associated Diarrhea in High Risk Adult Patients
Lead Sponsor:
Alison Schneider
Conditions:
Clostridium Difficile Diarrhea
Eligibility:
All Genders
55+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to test if metronidazole prophylaxis is effective in decreasing the incidence of hospital induced Clostridium Difficile diarrhea among patients at high risk for this infec...
Detailed Description
Clostridium Difficile infection or C. Diff (CDI) is an infection that causes severe diarrhea. Risk factors for this infection include hospitalization, the use of antibiotics, along with medications th...
Eligibility Criteria
Inclusion
- Inpatients \>55
- Proton Pump inhibitor / Histamine-2 Blocker
- On broad spectrum antibiotics (Zosyn and/or Ciprofloxacin). These two antibiotics are selected based on current hospital formulary/use
- Anticipated hospital stay \>48 hours
- Mental capacity (able to give informed written consent).
Exclusion
- Admission for CDI
- Existing diarrhea at admission
- Passed prophylactic window (\>48 hours on broad spectrum antibiotics)
- Unable to take PO at the time of evaluation for study entry
- No more than 14 days of broad spectrum antibiotics anticipated
- Medications with serious interactions/contraindications to that would be taken together with metronidazole (ex. Warfarin, disulfiram, phenytoin, calcineurin inhibitors)
- Inflammatory Bowel Disease
- Admission for colonic bowel surgery or h/o total/Subtotal colectomy)
- Hospice
- Mortality expected \<7days
- Previous CDI in the past 6 months
- Intensive care admission due to the difficulty of monitoring them
- Allergy to Metronidazole or other Antibiotics in protocol
- Patients with neuropathy
- History of heavy ethyl alcohol intake(greater than 3 drinks daily) or intake in past 24 hours,Solid organ transplant.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT02200328
Start Date
August 1 2014
End Date
March 1 2016
Last Update
May 17 2017
Active Locations (1)
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1
Cleveland Clinic Florida
Weston, Florida, United States, 33331