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Patients noncompliant with instructions and follow ups could not be completed.
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metronidazole | Experimental | Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days |
|
| Placebo | Placebo Comparator | Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metronidazole | Drug | Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Incidence of Clostridium Difficile Diarrhea in Both Study Groups at 30 Days Post Broad Spectrum Antibiotic Use. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Determine Differences in Clostridium Difficile Diarrhea Incidence Between Patients on Piperacillin/Tazobactam vs. Patients on Ciprofloxacin. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alison Schneider, M.D. | Cleveland Clinic Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Florida | Weston | Florida | 33331 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Incidence of Clostridium Difficile Diarrhea in Both Study Groups at 30 Days Post Broad Spectrum Antibiotic Use. | 0 participants were analyzed due to large number of patients not complying to the instructions and loss to follow up. | Posted | 30 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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Early termination:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Alison Schneider | Cleveland Clinic Florida | 9546595646 | schneia2@ccf.org |
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| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D008795 | Metronidazole |
| D013213 | Starch |
| ID | Term |
|---|---|
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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| Placebo | Drug | Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days |
|
|
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
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Secondary | Determine Differences in Clostridium Difficile Diarrhea Incidence Between Patients on Piperacillin/Tazobactam vs. Patients on Ciprofloxacin. | 0 participants were analyzed due to large number of patients not complying to the instructions and loss to follow up. | Posted | 30 days |
|
|
| 0 |
| 43 |
| 0 |
| 43 |
| EG001 | 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 | 0 | 33 | 0 | 33 |
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| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011134 | Polysaccharides |