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Unfeasible because of low accrual
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| Name | Class |
|---|---|
| American Urogynecologic Society | OTHER |
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The study will assess the risk of catheter associated urinary tract infection in women undergoing incontinence or reconstructive pelvic surgery. Women will be given an antibiotic or placebo at the time of catheter removal. The investigators hypothesize that prophylactic antibiotics will reduce the rate of infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bactrim | Drug | Bactrim DS BID for 3 days |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Urinary Tract Infection | Urinary tract infection diagnosis was obtained after confirmation with urine culture microbiology report. Infection was defined as >100,000 colony forming units/mL | 7 days following catheter removal |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew D Barber, MD MHS | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
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A total of 52 subjects were recruited.
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| ID | Title | Description |
|---|---|---|
| FG000 | Drug | Bactrim: Bactrim DS BID for 3 days |
| FG001 | Placebo | Placebo: Corn starch capsules |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Drug | Bactrim: Bactrim DS BID for 3 days Demographics data by group not available as this study was discontinued in 2013. Currently randomization data not available for reassessment. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Number of Participants With Urinary Tract Infection | Urinary tract infection diagnosis was obtained after confirmation with urine culture microbiology report. Infection was defined as >100,000 colony forming units/mL | Study terminated early. | Posted | Count of Participants | Participants | 7 days following catheter removal |
|
3-years while patients were in treatment and follow-up
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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 | Drug | Bactrim: Bactrim DS BID for 3 days | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lynn Borzi | Cleveland Clinic | 2164453158 | borzil@ccf.org |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D015662 | Trimethoprim, Sulfamethoxazole Drug Combination |
| ID | Term |
|---|---|
| D013420 | Sulfamethoxazole |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
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| Other |
Corn starch capsules |
|
Placebo: Corn starch capsules
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index | Body mass index (BMI) measured as kg/m^2 | Mean | Standard Deviation | kg/m^2 |
|
| Units | Counts |
|---|
| Participants |
|
|
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Placebo | Placebo: Corn starch capsules | 0 | 26 | 0 | 26 | 0 | 26 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D009930 |
| Organic Chemicals |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D014295 | Trimethoprim |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |