Conditions: Clostridium Difficile Diarrhea
Keywords: Clostridium difficile infection Diarrhea Flagyl Metronidazole
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 76
Healthy volunteers: no

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).

Arms:
arm 1: Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days arm 2: Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days

Interventions: intervention 1: Metronidazole intervention 2: Placebo
Intervention descriptions: intervention 1: Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days intervention 2: Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days

Protocol document: