Trial Outcomes & Findings for Randomized Trial of Culture Directed Versus Empiric Antibiotics for Urinary Tract Infections in Older Women (NCT NCT05726318)

Results Overview

Number and proportion of eligible subjects that were enrolled in the study

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

70 participants

Primary outcome timeframe

Through study completion, an average of 17.5 months

Results posted on

2025-08-27

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	35	35
Overall Study COMPLETED	31	31
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Randomized Trial of Culture Directed Versus Empiric Antibiotics for Urinary Tract Infections in Older Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Culture-directed Antibiotic n=35 Participants 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	Empiric Antibiotic n=35 Participants 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	Total n=70 Participants Total of all reporting groups
Age, Continuous	74.1 years STANDARD_DEVIATION 7.1 • n=93 Participants	75.7 years STANDARD_DEVIATION 6.8 • n=4 Participants	74.9 years STANDARD_DEVIATION 6.9 • n=27 Participants
Sex: Female, Male Female	35 Participants n=93 Participants	35 Participants n=4 Participants	70 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=93 Participants	34 Participants n=4 Participants	69 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) White	35 Participants n=93 Participants	34 Participants n=4 Participants	69 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Number of Participants with Diabetes Mellitus	5 Participants n=93 Participants	6 Participants n=4 Participants	11 Participants n=27 Participants
BMI	30.5 kg/m^2 STANDARD_DEVIATION 7.6 • n=93 Participants	28.5 kg/m^2 STANDARD_DEVIATION 6.1 • n=4 Participants	29.5 kg/m^2 STANDARD_DEVIATION 6.9 • n=27 Participants
Pelvic Floor Distress Inventory-20	137.9 units on a scale STANDARD_DEVIATION 59.9 • n=93 Participants	146.0 units on a scale STANDARD_DEVIATION 68.0 • n=4 Participants	142.0 units on a scale STANDARD_DEVIATION 63.7 • n=27 Participants

PRIMARY outcome

Timeframe: Through study completion, an average of 17.5 months

Population: There were 103 eligible participants in the study time frame

Number and proportion of eligible subjects that were enrolled in the study

Outcome measures

Outcome measures
Measure	Overall Number and Proportion of Eligible Subjects That Were Enrolled in the Study n=103 Participants Overall number and proportion of eligible subjects that were enrolled in the study	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 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. 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
Eligible Subjects That Were Enrolled in the Study	70 Participants	—

SECONDARY outcome

Timeframe: Through study completion, an average of 17.5 months

Overall number of persons that were screened for participation

Outcome measures

Outcome measures
Measure	Overall Number and Proportion of Eligible Subjects That Were Enrolled in the Study n=131 Participants Overall number and proportion of eligible subjects that were enrolled in the study	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 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. 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
Number of Persons That Were Screened for Participation	131 Participants	—

SECONDARY outcome

Timeframe: 30 days

Number of person screened who met include/exclusion criteria divided by number participants screened

Outcome measures

Outcome measures
Measure	Overall Number and Proportion of Eligible Subjects That Were Enrolled in the Study n=131 Participants Overall number and proportion of eligible subjects that were enrolled in the study	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 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. 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
Proportion of Persons Screened Who Met Inclusion/Exclusion Criteria	103 Participants	—

SECONDARY outcome

Timeframe: 30 days

Number of person screened who declined or were ineligible divided by number participants screened

Outcome measures

Outcome measures
Measure	Overall Number and Proportion of Eligible Subjects That Were Enrolled in the Study n=131 Participants Overall number and proportion of eligible subjects that were enrolled in the study	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 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. 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
Proportion of Persons Screened Who Declined Participation or Were Ineligible	43 Participants	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Overall Number and Proportion of Eligible Subjects That Were Enrolled in the Study n=35 Participants Overall number and proportion of eligible subjects that were enrolled in the study	Empiric Antibiotic n=35 Participants 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. 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
Proportion of Participants Enrolled Who Completed the Study	30 Participants	31 Participants

SECONDARY outcome

Timeframe: Through study completion, an average of 17.5 months

Population: How many of the total 70 participants we enrolled per month

number of participants that were enrolled each month

Outcome measures

Outcome measures
Measure	Overall Number and Proportion of Eligible Subjects That Were Enrolled in the Study n=70 Participants Overall number and proportion of eligible subjects that were enrolled in the study	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 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. 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
Monthly Enrollment Rate	4 participants enrolled per month Interval 2.0 to 5.0	—

SECONDARY outcome

Timeframe: 30 days

Number of persons enrolled who completed all study procedures (completed all 4 follow-up questionnaires) divided by number participants enrolled

Outcome measures

Outcome measures
Measure	Overall Number and Proportion of Eligible Subjects That Were Enrolled in the Study n=35 Participants Overall number and proportion of eligible subjects that were enrolled in the study	Empiric Antibiotic n=35 Participants 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. 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
Proportion of Enrolled Participants That Completed All Study Procedures	30 Participants	31 Participants

SECONDARY outcome

Timeframe: 30 days

Number of persons enrolled who took alternative agents for management of symptoms divided by number participants enrolled

Outcome measures

Outcome measures
Measure	Overall Number and Proportion of Eligible Subjects That Were Enrolled in the Study n=35 Participants Overall number and proportion of eligible subjects that were enrolled in the study	Empiric Antibiotic n=35 Participants 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. 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
Proportion of Enrolled Participants That Took Alternative Agents for Management of Symptoms	16 Participants	10 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Overall Number and Proportion of Eligible Subjects That Were Enrolled in the Study n=35 Participants Overall number and proportion of eligible subjects that were enrolled in the study	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 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. 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
Proportion of Participants in the Culture-directed Arm That Acquired Off-protocol Antibiotics for Their Symptoms	1 Participants	—

SECONDARY outcome

Timeframe: 30 days

Number of persons enrolled who completed all electronic surveys divided by number participants enrolled

Outcome measures

Outcome measures
Measure	Overall Number and Proportion of Eligible Subjects That Were Enrolled in the Study n=35 Participants Overall number and proportion of eligible subjects that were enrolled in the study	Empiric Antibiotic n=35 Participants 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. 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
Proportion of Enrolled Participants That Completed Electronic Surveys	30 Participants	31 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Overall Number and Proportion of Eligible Subjects That Were Enrolled in the Study n=31 Participants Overall number and proportion of eligible subjects that were enrolled in the study	Empiric Antibiotic n=31 Participants 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. 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
Clinical Success at 14 Days	19 Participants	12 Participants

Adverse Events

Culture-directed Antibiotic

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Empiric Antibiotic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Culture-directed Antibiotic n=35 participants at risk 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	Empiric Antibiotic n=35 participants at risk 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
Gastrointestinal disorders Nausea/Vomiting Symptoms	8.6% 3/35 • Number of events 3 • 28 days	0.00% 0/35 • 28 days
Gastrointestinal disorders Diarrhea	14.3% 5/35 • Number of events 5 • 28 days	0.00% 0/35 • 28 days
Skin and subcutaneous tissue disorders Rash	0.00% 0/35 • 28 days	0.00% 0/35 • 28 days

Additional Information

Megan Bradley, MD

University of Pittsburgh

Phone: 412-641-3189

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place