NCT02200328

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

Efficacy of Metronidazole Prophylaxis Against Clostridium Difficile-Associated Diarrhea in High Risk Adult Patients: A Randomized Clinical Trial

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Alison Schneider · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Metronidazole	Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days
DRUG	Placebo	Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days

Timeline

• Start date: 2014-08-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2014-07-25
• Last updated: 2017-05-17
• Results posted: 2016-06-10

Locations

1 site across 1 country: United States