Clostridium Difficile Diarrhea Clinical Trial
Official title:
Efficacy of Metronidazole Prophylaxis Against Clostridium Difficile-Associated Diarrhea in High Risk Adult Patients: A Randomized Clinical Trial
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.
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).
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Prevention
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