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Urinary tract infection (UTI) is a very common problem in young healthy women, afflicting approximately one-half of women by their late 20s. One of the most common antibiotics used to treat UTIs is ciprofloxacin, usually for a total of three days. However, increasing resistance to this antibiotic has raised concerns about its overuse for cystitis and generated interest in alternative agents. An alternative antibiotic which is approved for use in UTIs is cefpodoxime. However, there are few studies evaluating the efficacy and tolerance of this compound when given in a 3-day regimen as is commonly used for treatment of UTI. The major purpose of this study is to assess the efficacy and tolerance of a 3-day regimen of cefpodoxime versus ciprofloxacin for treatment of acute uncomplicated cystitis.
Procedures subjects will undergo once they have read and signed the consent are:
Questions about their medical and sexual history and current symptoms of UTI. They will be asked to provide a urine and peri-urethral sample and then are randomly assigned to one of the two treatment groups.They will be given a sheet to record symptoms at home. They will be asked to return to the clinic in 5-9 and 28-30 days after completing antibiotic therapy.Follow-up questions will be asked and urine and peri-urethral will be self collected at each visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cefpodoxime | Experimental | Cefpodoxime 100mg twice a day(BID)for 3 days |
|
| Ciprofloxacin | Active Comparator | Ciprofloxacin 250mg twice a day (BID)for 3 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cefpodoxime | Drug | Cefpodoxime 100mg twice a day(BID)for 3 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Cure | Participants with clinical cure, i.e. free of urinary tract symptoms and requiring no further antibiotic treatment, to assess the efficacy of a 3-day regimen of cefpodoxime compared to ciprofloxacin | 28-30 days post therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiologic Cure | Elimination or decrease of causative uropathogen(s) in the mid-stream urine culture at follow-up | 1-15 days post therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann Stapleton, MD | University of Washington, Department of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | United States | ||
| University of Washington |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22318279 | Result | Hooton TM, Roberts PL, Stapleton AE. Cefpodoxime vs ciprofloxacin for short-course treatment of acute uncomplicated cystitis: a randomized trial. JAMA. 2012 Feb 8;307(6):583-9. doi: 10.1001/jama.2012.80. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ciprofloxacin | Ciprofloxacin 250 mg BID X 3 days |
| FG001 | Cefpodoxime | Cefpodoxime 100 mg BID X 3 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ciprofloxacin | Ciprofloxacin 250 mg BID X 3 days |
| BG001 | Cefpodoxime | Cefpodoxime 100 mg BID X 3 days |
| 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 | Clinical Cure | Participants with clinical cure, i.e. free of urinary tract symptoms and requiring no further antibiotic treatment, to assess the efficacy of a 3-day regimen of cefpodoxime compared to ciprofloxacin | modified ITT | Posted | Number | participants | 28-30 days post therapy |
|
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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 | Ciprofloxacin | Ciprofloxacin 250 mg BID X 3 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| gastrointestinal(GI) side effects | Gastrointestinal disorders | Systematic Assessment | nausea, vomiting, loose stools, abdominal discomfort, other GI |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ann Stapleton, MD | University Of Washington | 206-616-4121 | stapl@uw.edu |
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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 |
|---|---|
| D000097623 | Cefpodoxime |
| D002939 | Ciprofloxacin |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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| Ciprofloxacin |
| Drug |
Ciprofloxacin 250mg twice a day (BID)for 3 days |
|
| Seattle |
| Washington |
| 98195 |
| United States |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Microbiologic Cure | Elimination or decrease of causative uropathogen(s) in the mid-stream urine culture at follow-up | Per protocol. Participants were eligible for analysis if they had an enrollment urine containing uropathogens and a urine specimen taken at follow-up. | Posted | Number | participants | 1-15 days post therapy |
|
|
|
| 0 |
| 150 |
| 41 |
| 137 |
| EG001 | Cefpodoxime | Cefpodoxime 100 mg BID X 3 days | 0 | 150 | 37 | 137 |
|
| central nervous system (CNS) side effect | Nervous system disorders | Systematic Assessment | headache, dizziness |
|
| vaginal side effects | Reproductive system and breast disorders | Systematic Assessment | vaginal discomfort, discharge, itching, or self-diagnosed yeast |
|
| nausea | Gastrointestinal disorders | Systematic Assessment | included under GI side effects |
|
| loose stools | Gastrointestinal disorders | Systematic Assessment | included under GI side effects |
|
| abdominal discomfort | Gastrointestinal disorders | Systematic Assessment | included under GI side effects |
|
| headache | Nervous system disorders | Systematic Assessment | included under CNS side effects |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |