Trial Outcomes & Findings for Patient-Directed Antimicrobial Duration in Acute Uncomplicated Pyelonephritis (NCT NCT06127160)
NCT ID: NCT06127160
Last Updated: 2026-08-03
Results Overview
Percentage of participants that complete all study activities and follow-up through 90 days
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
39 participants
Primary outcome timeframe
90 days
Results posted on
2026-08-03
Participant Flow
We conducted a double-blind, pilot randomized trial at three U.S. emergency departments (EDs) at academic medical centers from 2024-25.
Participant milestones
| Measure |
Fixed Duration Treatment
Fixed duration (i.e., complete the full course of therapy regardless of symptom resolution). Fixed duration-assigned participants received oral cephalexin 500 mg capsules, two capsules by mouth three times daily for 10 days.
|
Patient-directed Antimicrobial Duration (PDAD)
PDAD-assigned participants received oral cephalexin 500 mg capsules, two capsules by mouth three times daily, with treatment discontinued after symptom resolution for 24 hours.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
20
|
|
Overall Study
End of Treatment Visit (14 days)
|
19
|
17
|
|
Overall Study
Test of Cure Visit (30 days)
|
17
|
17
|
|
Overall Study
COMPLETED
|
17
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Total
n=39 Participants
Total of all reporting groups
|
Fixed Duration Treatment
n=19 Participants
Fixed duration (i.e., complete the full course of therapy regardless of symptom resolution). Fixed duration-assigned participants received oral cephalexin 500 mg capsules, two capsules by mouth three times daily for 10 days.
|
Patient-directed Antimicrobial Duration (PDAD)
n=20 Participants
PDAD-assigned participants received oral cephalexin 500 mg capsules, two capsules by mouth three times daily, with treatment discontinued after symptom resolution for 24 hours.
|
|---|---|---|---|
|
Age, Continuous
|
32 Years
n=39 Participants
|
35 Years
n=19 Participants
|
31 Years
n=20 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=39 Participants
|
19 Participants
n=19 Participants
|
20 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=20 Participants
|
|
Race and Ethnicity Not Collected
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
—
|
—
|
PRIMARY outcome
Timeframe: 90 daysPercentage of participants that complete all study activities and follow-up through 90 days
Outcome measures
| Measure |
Fixed Duration Treatment
n=17 Participants
Fixed duration (i.e., complete the full course of therapy regardless of symptom resolution). Fixed duration-assigned participants received oral cephalexin 500 mg capsules, two capsules by mouth three times daily for 10 days.
|
Patient-directed Antimicrobial Duration (PDAD)
n=16 Participants
PDAD-assigned participants received oral cephalexin 500 mg capsules, two capsules by mouth three times daily, with treatment discontinued after symptom resolution for 24 hours.
|
|---|---|---|
|
Feasibility of Completing All Clinical Trial Activities and Follow-up
|
17 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: 30 daysParticipant does not require any additional antimicrobial treatment and they do not have a recurrence of symptoms after initial clinical improvement.
Outcome measures
| Measure |
Fixed Duration Treatment
n=17 Participants
Fixed duration (i.e., complete the full course of therapy regardless of symptom resolution). Fixed duration-assigned participants received oral cephalexin 500 mg capsules, two capsules by mouth three times daily for 10 days.
|
Patient-directed Antimicrobial Duration (PDAD)
n=17 Participants
PDAD-assigned participants received oral cephalexin 500 mg capsules, two capsules by mouth three times daily, with treatment discontinued after symptom resolution for 24 hours.
|
|---|---|---|
|
Sustained Clinical Cure
|
14 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: 30 daysThe bacterial pathogen found at trial entry is sustained to fewer than 1000 CFU/mL.
Outcome measures
| Measure |
Fixed Duration Treatment
n=10 Participants
Fixed duration (i.e., complete the full course of therapy regardless of symptom resolution). Fixed duration-assigned participants received oral cephalexin 500 mg capsules, two capsules by mouth three times daily for 10 days.
|
Patient-directed Antimicrobial Duration (PDAD)
n=11 Participants
PDAD-assigned participants received oral cephalexin 500 mg capsules, two capsules by mouth three times daily, with treatment discontinued after symptom resolution for 24 hours.
|
|---|---|---|
|
Sustained Microbiological Cure Defined as the Bacterial Pathogen Found at Trial Entry is Reduced to Fewer Than 10^3 Cfu/mL and no New Pathogen >10^3 Cfu/mL,
|
10 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 15-21 daysParticipant does not require any additional antimicrobial treatment and they do not have a recurrence of symptoms after initial clinical improvement AND the bacterial pathogen found at trial entry is reduced to fewer than 1000 CFU/mL.
Outcome measures
| Measure |
Fixed Duration Treatment
n=17 Participants
Fixed duration (i.e., complete the full course of therapy regardless of symptom resolution). Fixed duration-assigned participants received oral cephalexin 500 mg capsules, two capsules by mouth three times daily for 10 days.
|
Patient-directed Antimicrobial Duration (PDAD)
n=17 Participants
PDAD-assigned participants received oral cephalexin 500 mg capsules, two capsules by mouth three times daily, with treatment discontinued after symptom resolution for 24 hours.
|
|---|---|---|
|
Clinical Cure Rate at the End of Treatment
|
15 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Day 15-21Outcome measures
| Measure |
Fixed Duration Treatment
n=17 Participants
Fixed duration (i.e., complete the full course of therapy regardless of symptom resolution). Fixed duration-assigned participants received oral cephalexin 500 mg capsules, two capsules by mouth three times daily for 10 days.
|
Patient-directed Antimicrobial Duration (PDAD)
n=17 Participants
PDAD-assigned participants received oral cephalexin 500 mg capsules, two capsules by mouth three times daily, with treatment discontinued after symptom resolution for 24 hours.
|
|---|---|---|
|
Microbiological Cure Rate at End of Treatment Defined as Defined as the Bacterial Pathogen Found at Trial Entry is Reduced to Fewer Than 10^3 Cfu/mL and no New Pathogen >10^3 Cfu/mL,
|
7 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 90 daysOutcome measures
| Measure |
Fixed Duration Treatment
n=17 Participants
Fixed duration (i.e., complete the full course of therapy regardless of symptom resolution). Fixed duration-assigned participants received oral cephalexin 500 mg capsules, two capsules by mouth three times daily for 10 days.
|
Patient-directed Antimicrobial Duration (PDAD)
n=17 Participants
PDAD-assigned participants received oral cephalexin 500 mg capsules, two capsules by mouth three times daily, with treatment discontinued after symptom resolution for 24 hours.
|
|---|---|---|
|
Additional Health Care Visits With the Chief Complaint of Urinary Tract Infection
|
1 Participants
|
0 Participants
|
Adverse Events
Fixed Duration Treatment
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Patient-directed Antimicrobial Duration (PDAD)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fixed Duration Treatment
n=19 participants at risk
Fixed duration (i.e., complete the full course of therapy regardless of symptom resolution). Fixed duration-assigned participants received oral cephalexin 500 mg capsules, two capsules by mouth three times daily for 10 days.
|
Patient-directed Antimicrobial Duration (PDAD)
n=20 participants at risk
PDAD-assigned participants received oral cephalexin 500 mg capsules, two capsules by mouth three times daily, with treatment discontinued after symptom resolution for 24 hours.
|
|---|---|---|
|
Infections and infestations
Yeast Infection
|
10.5%
2/19 • 30 days
Adverse event rates collected and assessed for all participants randomized to a study arm.
|
5.0%
1/20 • 30 days
Adverse event rates collected and assessed for all participants randomized to a study arm.
|
|
Gastrointestinal disorders
Nausea
|
15.8%
3/19 • 30 days
Adverse event rates collected and assessed for all participants randomized to a study arm.
|
0.00%
0/20 • 30 days
Adverse event rates collected and assessed for all participants randomized to a study arm.
|
|
Reproductive system and breast disorders
Burning/Itching/Pain in vaginal area
|
10.5%
2/19 • 30 days
Adverse event rates collected and assessed for all participants randomized to a study arm.
|
10.0%
2/20 • 30 days
Adverse event rates collected and assessed for all participants randomized to a study arm.
|
|
Nervous system disorders
Headache
|
5.3%
1/19 • 30 days
Adverse event rates collected and assessed for all participants randomized to a study arm.
|
0.00%
0/20 • 30 days
Adverse event rates collected and assessed for all participants randomized to a study arm.
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.3%
1/19 • 30 days
Adverse event rates collected and assessed for all participants randomized to a study arm.
|
10.0%
2/20 • 30 days
Adverse event rates collected and assessed for all participants randomized to a study arm.
|
|
Gastrointestinal disorders
Diarrhea
|
5.3%
1/19 • 30 days
Adverse event rates collected and assessed for all participants randomized to a study arm.
|
15.0%
3/20 • 30 days
Adverse event rates collected and assessed for all participants randomized to a study arm.
|
|
Nervous system disorders
Fatigue
|
5.3%
1/19 • 30 days
Adverse event rates collected and assessed for all participants randomized to a study arm.
|
0.00%
0/20 • 30 days
Adverse event rates collected and assessed for all participants randomized to a study arm.
|
|
Immune system disorders
Hives
|
0.00%
0/19 • 30 days
Adverse event rates collected and assessed for all participants randomized to a study arm.
|
5.0%
1/20 • 30 days
Adverse event rates collected and assessed for all participants randomized to a study arm.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/19 • 30 days
Adverse event rates collected and assessed for all participants randomized to a study arm.
|
5.0%
1/20 • 30 days
Adverse event rates collected and assessed for all participants randomized to a study arm.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place