Clinical trial NCT02200328: Efficacy of Metronidazole Prophylaxis Against Clostridium Difficile-Associated Diarrhea in High Risk Adult Patients
Official title: Efficacy of Metronidazole Prophylaxis Against Clostridium Difficile-Associated Diarrhea in High Risk Adult Patients: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Clostridium Difficile Diarrhea
Keywords: Clostridium difficile infection
Diarrhea
Flagyl
Metronidazole
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2014-07-25
Enrollment: 76
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 infection.

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 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.

Primary outcomes:
measure: The Incidence of Clostridium Difficile Diarrhea in Both Study Groups at 30 Days Post Broad Spectrum Antibiotic Use.
timeFrame: 30 days
Secondary outcomes:
measure: Determine Differences in Clostridium Difficile Diarrhea Incidence Between Patients on Piperacillin/Tazobactam vs. Patients on Ciprofloxacin.
timeFrame: 30 days
Other outcomes:
Locations:
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
Study officials:
affiliation: Cleveland Clinic Florida
name: Alison Schneider, M.D.
role: PRINCIPAL_INVESTIGATOR
References: