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Pilot study to compare the efficacy and safety of 3-day, twice-daily regimens of nitrofurantoin and ciprofloxacin in emergency department (ED) patients presenting with UBC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nitrofurantoin 100 mg | Active Comparator |
| |
| Ciprofloxacin 250 mg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days | Drug |
| ||
| ciprofloxacin 250 mg BID x 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinical Cure at Day 7 | Seven days after randomization, subjects received a telephone call to determine if their symptoms have completely resolved. Patients answers were limited to: Yes (clinical cure), No (treatment failure) | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nitrofurantoin 100 mg | Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days |
| FG001 | Ciprofloxacin 250 mg | ciprofloxacin 250 mg BID x 3 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Nitrofurantoin 100 mg | Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days |
| BG001 | Ciprofloxacin 250 mg | ciprofloxacin 250 mg BID x 3 days |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 Clinical Cure at Day 7 | Seven days after randomization, subjects received a telephone call to determine if their symptoms have completely resolved. Patients answers were limited to: Yes (clinical cure), No (treatment failure) | Posted | Number | participants | 7 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 | Nitrofurantoin 100 mg | Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days | 0 | 18 | 0 | 18 | 1 | 18 |
| EG001 | Ciprofloxacin 250 mg | ciprofloxacin 250 mg BID x 3 days | 0 | 17 | 0 | 17 | 1 | 17 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Rash |
| |
| Nausea | Gastrointestinal disorders | Non-systematic Assessment | Nausea and vomiting |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brett Faine, PI | University of Iowa | 319-310-8067 | brett-faine@uiowa.edu |
| ID | Term |
|---|---|
| D009582 | Nitrofurantoin |
| D002939 | Ciprofloxacin |
| ID | Term |
|---|---|
| D009581 | Nitrofurans |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D005663 | Furans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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