Efficacy of Metronidazole Prophylaxis Against Clostridium Difficile-Associated Diarrhea in High Risk Adult Patients

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Clostridium Difficile Diarrhea

In brief

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 infection.

Key facts

Study ID

NCT02200328

Run by

Alison Schneider

People needed

76

Starts

2014-08-01

Expected to finish

2016-03-01

Last updated by the study team

2017-05-17

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Cleveland Clinic Florida — Weston, Florida, United States

Full record on ClinicalTrials.gov

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