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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
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
Magee Women's Hospital of UPMC
Pittsburgh, Pennsylvania, United States
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
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
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
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
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
Monthly Enrollment Rate
number of participants that were enrolled each month
Time frame: 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
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Time frame: 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
Time frame: 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
Time frame: 30 days
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