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| ID | Type | Description | Link |
|---|---|---|---|
| DK131273 | Other Identifier | NIDDK | |
| R01DK131273 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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To evaluate the feasibility of recruiting eligible subjects into a randomized trial of a culture-directed versus empiric antibiotic strategy for patient-reported urinary tract infection symptoms in older women and the adherence to study procedures.
To evaluate A) the feasibility of recruiting eligible subjects into a randomized trial of a culture-directed versus empiric antibiotic strategy for patient-reported urinary tract infection (UTI) symptoms in older women and B) the adherence to study procedures. We will recruit and enroll women with a history of recurrent UTI (rUTI) from the Women's Center for Bladder and Pelvic Health and the University of Pittsburgh's Clinical and Translational Science Institute (CTSI) Pitt+Me® Research Registry. Once enrolled and randomized, women will be followed for a total of 28 days to document both clinical resolution at day 7 from symptom onset and adverse events. H1) Enrolling a total of 70 subjects in <1 year (at least 10% of eligible patients) will demonstrate feasibility of recruitment and H2) Documenting at least 70% patient compliance with study procedures will confirm patient adherence to study protocol. Exploratory Aim: To explore the safety of a culture-directed UTI treatment strategy and preliminary secondary outcomes of assigned treatments. H1) There will be an overall low number of adverse events and H2) Preliminary outcome data will help power future trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Culture-directed antibiotic | Other | Participants will be directed to refrain from taking antibiotics until results of urine culture are reported, which is expected within 48-72h. |
|
| Empiric antibiotic | Active Comparator | Antibiotic Protocol. For participants in the empiric Rx arm, we will choose an antibiotic with consideration of patient reported allergies, current medications and current Infectious Disease Society of American (IDSA) guidelines. If there is a contraindication to the first antibiotic on the list they will progress to the next option until a suitable selection is achieved. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antibiotics | Drug | Participants will be provided either nitrofurantoin 100 mg oral twice a day for 5 days, trimethoprim/sulfamethoxazole 875/125 oral twice a day for 3 days, fosfomycin 3g once oral, ciprofloxacin 250 mg oral twice a day for 5 days or cephalexin 500 mg oral twice a day for 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Eligible Subjects That Were Enrolled in the Study | Number and proportion of eligible subjects that were enrolled in the study | Through study completion, an average of 17.5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Persons That Were Screened for Participation | Overall number of persons that were screened for participation | Through study completion, an average of 17.5 months |
| Proportion of Persons Screened Who Met Inclusion/Exclusion Criteria |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Success at 14 Days | Score of <1 on question 1 (urinary burning),3 (urinary urgency) and 5 (urinary frequency) on Urinary Tract Infection Symptom Assessment at day 14. A lower scale correlates with better symptoms with 0 being no symptoms and 1 being "little" symptoms. | 14 days |
Inclusion Criteria:
Female biologic Sex
Age ≥65 years old
History of recurrent UTI per patient report of greater than 2 UTIs in the last 6 months or 3 UTIs in the last year
Patient reported UTI defined as:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Megan S Bradley | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Magee Women's Hospital of UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
Will review each request individually and work with University of Pittsburgh Research Agreements to share.
1 year after completion
unknown at this time
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| ID | Title | Description |
|---|---|---|
| FG000 | Culture-directed Antibiotic | Participants will be directed to refrain from taking antibiotics until results of urine culture are reported, which is expected within 48-72h. Antibiotics: Participants will be provided either nitrofurantoin 100 mg oral twice a day for 5 days, trimethoprim/sulfamethoxazole 875/125 oral twice a day for 3 days, fosfomycin 3g once oral, ciprofloxacin 250 mg oral twice a day for 5 days or cephalexin 500 mg oral twice a day for 5 days |
| FG001 | Empiric Antibiotic | Antibiotic Protocol. For participants in the empiric Rx arm, we will choose an antibiotic with consideration of patient reported allergies, current medications and current Infectious Disease Society of America (IDSA) guidelines. If there is a contraindication to the first antibiotic on the list they will progress to the next option until a suitable selection is achieved. Antibiotics: Participants will be provided either nitrofurantoin 100 mg oral twice a day for 5 days, trimethoprim/sulfamethoxazole 875/125 oral twice a day for 3 days, fosfomycin 3g once oral, ciprofloxacin 250 mg oral twice a day for 5 days or cephalexin 500 mg oral twice a day for 5 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Culture-directed Antibiotic | Participants will be directed to refrain from taking antibiotics until results of urine culture are reported, which is expected within 48-72h. Antibiotics: Participants will be provided either nitrofurantoin 100 mg oral twice a day for 5 days, trimethoprim/sulfamethoxazole 875/125 oral twice a day for 3 days, fosfomycin 3g once oral, ciprofloxacin 250 mg oral twice a day for 5 days or cephalexin 500 mg oral twice a day for 5 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 | Eligible Subjects That Were Enrolled in the Study | Number and proportion of eligible subjects that were enrolled in the study | There were 103 eligible participants in the study time frame | Posted | Count of Participants | Participants | Through study completion, an average of 17.5 months |
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|
28 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 | Culture-directed Antibiotic | Participants will be directed to refrain from taking antibiotics until results of urine culture are reported, which is expected within 48-72h. Antibiotics: Participants will be provided either nitrofurantoin 100 mg oral twice a day for 5 days, trimethoprim/sulfamethoxazole 875/125 oral twice a day for 3 days, fosfomycin 3g once oral, ciprofloxacin 250 mg oral twice a day for 5 days or cephalexin 500 mg oral twice a day for 5 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea/Vomiting Symptoms | Gastrointestinal disorders | Systematic Assessment | Nausea, vomiting |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Megan Bradley, MD | University of Pittsburgh | 412-641-3189 | bradleym4@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 1, 2025 | Jul 1, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 16, 2024 | Jul 1, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000900 | Anti-Bacterial Agents |
| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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|
Number of person screened who met include/exclusion criteria divided by number participants screened
| 30 days |
| Proportion of Persons Screened Who Declined Participation or Were Ineligible | Number of person screened who declined or were ineligible divided by number participants screened | 30 days |
| Proportion of Participants Enrolled Who Completed the Study | Number of persons enrolled who completed the study (at least one follow-up questionnaire and completed the day 28 questionnaire) divided by number participants enrolled | 30 days |
| Monthly Enrollment Rate | number of participants that were enrolled each month | Through study completion, an average of 17.5 months |
| Proportion of Enrolled Participants That Completed All Study Procedures | Number of persons enrolled who completed all study procedures (completed all 4 follow-up questionnaires) divided by number participants enrolled | 30 days |
| Proportion of Enrolled Participants That Took Alternative Agents for Management of Symptoms | Number of persons enrolled who took alternative agents for management of symptoms divided by number participants enrolled | 30 days |
| Proportion of Participants in the Culture-directed Arm That Acquired Off-protocol Antibiotics for Their Symptoms | Number of participants in the culture-directed arm that acquired off-protocol antibiotics for their symptoms divided by the number of participants in the culture-directed arm | 30 days |
| Proportion of Enrolled Participants That Completed Electronic Surveys | Number of persons enrolled who completed all electronic surveys divided by number participants enrolled | 30 days |
| BG001 | Empiric Antibiotic | Antibiotic Protocol. For participants in the empiric Rx arm, we will choose an antibiotic with consideration of patient reported allergies, current medications and current IDSA guidelines. If there is a contraindication to the first antibiotic on the list they will progress to the next option until a suitable selection is achieved. Antibiotics: Participants will be provided either nitrofurantoin 100 mg oral twice a day for 5 days, trimethoprim/sulfamethoxazole 875/125 oral twice a day for 3 days, fosfomycin 3g once oral, ciprofloxacin 250 mg oral twice a day for 5 days or cephalexin 500 mg oral twice a day for 5 days |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Number of Participants with Diabetes Mellitus | Count of Participants | Participants |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| Pelvic Floor Distress Inventory-20 | The Pelvic Floor Distress Inventory - Short Form 20 (PFDI-20) is a validated, patient-reported outcome measure that assesses symptom distress related to pelvic floor disorders. The PFDI-20 consists of 20 items divided into three subscales: Each item is scored from 0 to 4. Each subscale is scored by: Calculating the mean of the answered items in that subscale and multiplying the mean by 25. The total PFDI-20 score is the sum of the three subscale scores. Interpretation of Scores: Higher scores represent worse pelvic floor symptom distress. | Mean | Standard Deviation | units on a scale |
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| Secondary | Number of Persons That Were Screened for Participation | Overall number of persons that were screened for participation | Posted | Count of Participants | Participants | Through study completion, an average of 17.5 months |
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| Secondary | Proportion of Persons Screened Who Met Inclusion/Exclusion Criteria | Number of person screened who met include/exclusion criteria divided by number participants screened | Posted | Count of Participants | Participants | 30 days |
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| Secondary | Proportion of Persons Screened Who Declined Participation or Were Ineligible | Number of person screened who declined or were ineligible divided by number participants screened | Posted | Count of Participants | Participants | 30 days |
|
|
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| Secondary | Proportion of Participants Enrolled Who Completed the Study | Number of persons enrolled who completed the study (at least one follow-up questionnaire and completed the day 28 questionnaire) divided by number participants enrolled | Posted | Count of Participants | Participants | 30 days |
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|
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| Secondary | Monthly Enrollment Rate | number of participants that were enrolled each month | How many of the total 70 participants we enrolled per month | Posted | Median | Inter-Quartile Range | participants enrolled per month | Through study completion, an average of 17.5 months |
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| Secondary | Proportion of Enrolled Participants That Completed All Study Procedures | Number of persons enrolled who completed all study procedures (completed all 4 follow-up questionnaires) divided by number participants enrolled | Posted | Count of Participants | Participants | 30 days |
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| Secondary | Proportion of Enrolled Participants That Took Alternative Agents for Management of Symptoms | Number of persons enrolled who took alternative agents for management of symptoms divided by number participants enrolled | Posted | Count of Participants | Participants | 30 days |
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| Secondary | Proportion of Participants in the Culture-directed Arm That Acquired Off-protocol Antibiotics for Their Symptoms | Number of participants in the culture-directed arm that acquired off-protocol antibiotics for their symptoms divided by the number of participants in the culture-directed arm | Posted | Count of Participants | Participants | 30 days |
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| Secondary | Proportion of Enrolled Participants That Completed Electronic Surveys | Number of persons enrolled who completed all electronic surveys divided by number participants enrolled | Posted | Count of Participants | Participants | 30 days |
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| Other Pre-specified | Clinical Success at 14 Days | Score of <1 on question 1 (urinary burning),3 (urinary urgency) and 5 (urinary frequency) on Urinary Tract Infection Symptom Assessment at day 14. A lower scale correlates with better symptoms with 0 being no symptoms and 1 being "little" symptoms. | Posted | Count of Participants | Participants | 14 days |
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| 0 |
| 35 |
| 0 |
| 35 |
| 5 |
| 35 |
| EG001 | Empiric Antibiotic | Antibiotic Protocol. For participants in the empiric Rx arm, we will choose an antibiotic with consideration of patient reported allergies, current medications and current IDSA guidelines. If there is a contraindication to the first antibiotic on the list they will progress to the next option until a suitable selection is achieved. Antibiotics: Participants will be provided either nitrofurantoin 100 mg oral twice a day for 5 days, trimethoprim/sulfamethoxazole 875/125 oral twice a day for 3 days, fosfomycin 3g once oral, ciprofloxacin 250 mg oral twice a day for 5 days or cephalexin 500 mg oral twice a day for 5 days | 0 | 35 | 0 | 35 | 0 | 35 |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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