Clostridium Difficile Diarrhea
Conditions
Keywords
Clostridium difficile infection, Diarrhea, Flagyl, Metronidazole
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).
Interventions
DRUGMetronidazole
Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days
DRUGPlacebo
Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days
Sponsors
Alison Schneider
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Incidence of Clostridium Difficile Diarrhea in Both Study Groups at 30 Days Post Broad Spectrum Antibiotic Use. | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| Determine Differences in Clostridium Difficile Diarrhea Incidence Between Patients on Piperacillin/Tazobactam vs. Patients on Ciprofloxacin. | 30 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Metronidazole Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days
Metronidazole: Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days | 43 |
| Placebo Placebo(Corn starch pill) orally 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 | 33 |
| Total | 76 |
Baseline characteristics
| Characteristic | Metronidazole | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 71 years | 71.8 years | 71.4 years |
| Region of Enrollment United States | 43 participants | 33 participants | 76 participants |
| Sex: Female, Male Female | 18 Participants | 14 Participants | 32 Participants |
| Sex: Female, Male Male | 25 Participants | 19 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 43 | 0 / 33 |
| serious Total, serious adverse events | 0 / 43 | 0 / 33 |
Outcome results
Primary
The Incidence of Clostridium Difficile Diarrhea in Both Study Groups at 30 Days Post Broad Spectrum Antibiotic Use.
Time frame: 30 days
Population: 0 participants were analyzed due to large number of patients not complying to the instructions and loss to follow up.
Secondary
Determine Differences in Clostridium Difficile Diarrhea Incidence Between Patients on Piperacillin/Tazobactam vs. Patients on Ciprofloxacin.
Time frame: 30 days
Population: 0 participants were analyzed due to large number of patients not complying to the instructions and loss to follow up.