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

NCT ID: NCT02200328

Last Updated: 2017-05-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2016-03-31

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).

Conditions

Clostridium Difficile Diarrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Metronidazole

Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days

Group Type: EXPERIMENTAL

Metronidazole

Intervention Type: DRUG

Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days

Placebo

Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days

Interventions

Metronidazole

Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days

Intervention Type: DRUG

Placebo

Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days

Intervention Type: DRUG

Other Intervention Names

Flagyl; corn starch pill

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.

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alison Schneider

OTHER

Sponsor Role: lead

Responsible Party

Alison Schneider

M.D

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Alison Schneider, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Florida

Locations

Cleveland Clinic Florida

Weston, Florida, United States

Countries

United States

Other Identifiers

FLA14-061

Identifier Type: -

Identifier Source: org_study_id