UTI
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGAntibiotics
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
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Megan Bradley
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
65 Years to No maximum
Healthy volunteers
No
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: * Dysuria, increased urinary urgency/frequency and/or suprapubic pain
Exclusion criteria
* Male biologic sex * Age \<65 years old * History of augmentation cystoplasty or cystectomy * Currently performing clean intermittent self-catheterization * Current indwelling foley catheter * Urinary tract instrumentation (i.e., cystourethroscopy, foley catheter placement) in the last 30 days * Undergoing treatment for malignancy * History of either confirmed or patient reported pyelonephritis and/or urosepsis * Cirrhosis and/or end stage liver disease * Chronic kidney disease with most recent estimated glomerular filtration rate \<50 ml/min * Dementia and/or currently reside in skilled nursing facility * Current high-dose chronic steroids (\>20mg/day of prednisone) * Previous solid organ transplant * Provider concern for pyelonephritis and/or sepsis (i.e., fevers) * Unwilling or unable to comply with study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eligible Subjects That Were Enrolled in the Study | Through study completion, an average of 17.5 months | Number and proportion of eligible subjects that were enrolled in the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Persons That Were Screened for Participation | Through study completion, an average of 17.5 months | Overall number of persons that were screened for participation |
| Proportion of Persons Screened Who Met Inclusion/Exclusion Criteria | 30 days | Number of person screened who met include/exclusion criteria divided by number participants screened |
| Proportion of Persons Screened Who Declined Participation or Were Ineligible | 30 days | Number of person screened who declined or were ineligible divided by number participants screened |
| Proportion of Participants Enrolled Who Completed the Study | 30 days | 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 |
| Proportion of Enrolled Participants That Completed All Study Procedures | 30 days | Number of persons enrolled who completed all study procedures (completed all 4 follow-up questionnaires) divided by number participants enrolled |
| Proportion of Enrolled Participants That Took Alternative Agents for Management of Symptoms | 30 days | Number of persons enrolled who took alternative agents for management of symptoms divided by number participants enrolled |
| Proportion of Participants in the Culture-directed Arm That Acquired Off-protocol Antibiotics for Their Symptoms | 30 days | 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 |
| Proportion of Enrolled Participants That Completed Electronic Surveys | 30 days | Number of persons enrolled who completed all electronic surveys divided by number participants enrolled |
| Monthly Enrollment Rate | Through study completion, an average of 17.5 months | number of participants that were enrolled each month |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success at 14 Days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 35 |
| 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 | 35 |
| Total | 70 |
Baseline characteristics
| Characteristic | Empiric Antibiotic | Total | Culture-directed Antibiotic |
|---|---|---|---|
| Age, Continuous | 75.7 years STANDARD_DEVIATION 6.8 | 74.9 years STANDARD_DEVIATION 6.9 | 74.1 years STANDARD_DEVIATION 7.1 |
| BMI | 28.5 kg/m^2 STANDARD_DEVIATION 6.1 | 29.5 kg/m^2 STANDARD_DEVIATION 6.9 | 30.5 kg/m^2 STANDARD_DEVIATION 7.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants | 69 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Number of Participants with Diabetes Mellitus | 6 Participants | 11 Participants | 5 Participants |
| Pelvic Floor Distress Inventory-20 | 146.0 units on a scale STANDARD_DEVIATION 68 | 142.0 units on a scale STANDARD_DEVIATION 63.7 | 137.9 units on a scale STANDARD_DEVIATION 59.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 34 Participants | 69 Participants | 35 Participants |
| Sex: Female, Male Female | 35 Participants | 70 Participants | 35 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 35 |
| other Total, other adverse events | 5 / 35 | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 |
Outcome results
Primary
Eligible Subjects That Were Enrolled in the Study
Number and proportion of eligible subjects that were enrolled in the study
Time frame: Through study completion, an average of 17.5 months
Population: There were 103 eligible participants in the study time frame
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overall Number and Proportion of Eligible Subjects That Were Enrolled in the Study | Eligible Subjects That Were Enrolled in the Study | 70 Participants |
Secondary
Monthly Enrollment Rate
number of participants that were enrolled each month
Time frame: Through study completion, an average of 17.5 months
Population: How many of the total 70 participants we enrolled per month
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overall Number and Proportion of Eligible Subjects That Were Enrolled in the Study | Monthly Enrollment Rate | 4 participants enrolled per month |
Secondary
Number of Persons That Were Screened for Participation
Overall number of persons that were screened for participation
Time frame: Through study completion, an average of 17.5 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overall Number and Proportion of Eligible Subjects That Were Enrolled in the Study | Number of Persons That Were Screened for Participation | 131 Participants |
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
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overall Number and Proportion of Eligible Subjects That Were Enrolled in the Study | Proportion of Enrolled Participants That Completed All Study Procedures | 30 Participants |
| Empiric Antibiotic | Proportion of Enrolled Participants That Completed All Study Procedures | 31 Participants |
p-value: 0.78Chi-squared
Secondary
Proportion of Enrolled Participants That Completed Electronic Surveys
Number of persons enrolled who completed all electronic surveys divided by number participants enrolled
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overall Number and Proportion of Eligible Subjects That Were Enrolled in the Study | Proportion of Enrolled Participants That Completed Electronic Surveys | 30 Participants |
| Empiric Antibiotic | Proportion of Enrolled Participants That Completed Electronic Surveys | 31 Participants |
p-value: 0.78Chi-squared
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
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overall Number and Proportion of Eligible Subjects That Were Enrolled in the Study | Proportion of Enrolled Participants That Took Alternative Agents for Management of Symptoms | 16 Participants |
| Empiric Antibiotic | Proportion of Enrolled Participants That Took Alternative Agents for Management of Symptoms | 10 Participants |
p-value: 0.68Chi-squared
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
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overall Number and Proportion of Eligible Subjects That Were Enrolled in the Study | Proportion of Participants Enrolled Who Completed the Study | 30 Participants |
| Empiric Antibiotic | Proportion of Participants Enrolled Who Completed the Study | 31 Participants |
p-value: 0.78Chi-squared
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
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overall Number and Proportion of Eligible Subjects That Were Enrolled in the Study | Proportion of Participants in the Culture-directed Arm That Acquired Off-protocol Antibiotics for Their Symptoms | 1 Participants |
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
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overall Number and Proportion of Eligible Subjects That Were Enrolled in the Study | Proportion of Persons Screened Who Declined Participation or Were Ineligible | 43 Participants |
Secondary
Proportion of Persons Screened Who Met Inclusion/Exclusion Criteria
Number of person screened who met include/exclusion criteria divided by number participants screened
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overall Number and Proportion of Eligible Subjects That Were Enrolled in the Study | Proportion of Persons Screened Who Met Inclusion/Exclusion Criteria | 103 Participants |
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.
Time frame: 14 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overall Number and Proportion of Eligible Subjects That Were Enrolled in the Study | Clinical Success at 14 Days | 19 Participants |
| Empiric Antibiotic | Clinical Success at 14 Days | 12 Participants |
p-value: 0.13Chi-squared