Efficacy of Metronidazole Prophylaxis Against Clostridium Difficile-Associated Diarrhea in High Risk Adult Patients
Information source: Cleveland Clinic Florida
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Clostridium Difficile Diarrhea
Intervention: Metronidazole (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Alison Schneider Official(s) and/or principal investigator(s):
Alison Schneider, M.D., Principal Investigator, Affiliation: Cleveland Clinic Florida
Overall contact:
Alison Schneider, M.D., Phone: 954-659-5646, Email: schneia2@ccf.org
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 infection.
Clinical Details
Official title: Efficacy of Metronidazole Prophylaxis Against Clostridium Difficile-Associated Diarrhea in High Risk Adult Patients: A Randomized Clinical Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Prevention
Primary outcome: The incidence of Clostridium Difficile diarrhea in both study groups at 30 days post broad spectrum antibiotic use.
Secondary outcome: Determine differences in Clostridium Difficile diarrhea incidence between patients on Piperacillin/Tazobactam vs. patients on Ciprofloxacin.
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 that decrease the acid in the stomach. This infection leads to a
disease which is difficult to treat and can cause serious complications including death in
rare cases. This infection also increases medical costs by prolonging hospital stays.
Metronidazole (known by the brand name Flagyl) is an antibiotic that has been available for
decades and has been used to treat this disease. Flagyl is approved by the Food and Drug
Administration for the treatment of C. diff infection. Recent research by the investigators
group has shown that hospitalized patients who took Flagyl had a decreased chance of getting
C. Diff infection. However, high quality studies are needed to better evaluate whether the
investigators can prevent C. Diff infection in high risk patients with the use of Flagyl.
The purpose of this study is to assess if metronidazole prophylaxis is effective in
decreasing the incidence of hospital induced Clostridium Difficile diarrhea among inpatients
at high risk for this infection.
High risk patient population are as defined below: taking a broad spectrum antibiotics
(piperacillin/tazobactam-Zosyn; Ciprofloxacin).
Eligibility
Minimum age: 55 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
Alison Schneider, M.D., Phone: 954-659-5646, Email: schneia2@ccf.org
Cleveland Clinic Florida, Weston, Florida 33331, United States; Recruiting
Alison Schneider, M.D., Phone: 954-659-5646, Email: schneia2@ccf.org
Alison Schneider, M.D., Principal Investigator
Additional Information
Starting date: August 2014
Last updated: May 30, 2015
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