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

Alison Schneider

Status and phase

Terminated

Phase 4

Conditions

Clostridium Difficile Diarrhea

Treatments

Drug: Placebo

Drug: Metronidazole

Study type

Interventional

Funder types

Other

Identifiers

NCT02200328

FLA14-061

Details and patient eligibility

About

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.

Full 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).

Enrollment

76 patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

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.