A Phase 4 interventional study of Cephalexin and Cephalexin or placebo in Pyelonephritis Acute, sponsored by Brett A Faine. Completed at 2 sites in United States. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by Brett A Faine · Phase 4, Interventional, and Treatment
This pilot study will randomize 40 female patients with acute uncomplicated pyelonephritis to receive standard duration of therapy versus patient-directed antimicrobial duration (PDAD). The primary objectives of this pilot trial are to determine the feasibility and safety of conducting a full-scale multi-center randomized controlled trial.
Following informed consent, patients will be randomized to receive 10 days of cephalexin or PDAD (minimum of 3 days of cephalexin followed by placebo once patient reports 24 hours of symptom resolution). Patients will be evaluated at day 1 in-person, then daily using a mobile cellphone application to assess acute uncomplicated pyelonephritis (AUP) symptoms and quality of life (QOL). Urine samples will be collected at in-person visits at day 1, 3 weeks, and 4 weeks. Study feasibility will be assessed through day 90.
Brett A Faine is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion:
Drug: Cephalexin
Drug: Cephalexin or placebo
Cephalexin 1000 mg by mouth 3 times daily for 10 days
Cephalexin 1000 mg by mouth 3 times daily for a minimum of 3 days, once participant reports symptom resolution for 24 hours they will switch to placebo for remainder of 10 days of treatment.
Feasibility of Completing All Clinical Trial Activities and Follow-up
Percentage of participants that complete all study activities and follow-up through 90 days
Time frame: 90 days
Sustained Clinical Cure
Participant does not require any additional antimicrobial treatment and they do not have a recurrence of symptoms after initial clinical improvement.
Time frame: 30 days
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,
The bacterial pathogen found at trial entry is sustained to fewer than 1000 CFU/mL.
Time frame: 30 days
Clinical Cure Rate at the End of Treatment
Participant 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.
Time frame: 15-21 days
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,
Time frame: Day 15-21
Additional Health Care Visits With the Chief Complaint of Urinary Tract Infection
Time frame: 90 days
We conducted a double-blind, pilot randomized trial at three U.S. emergency departments (EDs) at academic medical centers from 2024-25.
| Milestone | Fixed Duration Treatment | Patient-directed Antimicrobial Duration (PDAD) |
|---|---|---|
| Started | 19 | 20 |
| End of treatment visit (14 days) | 19 | 17 |
| Test of cure visit (30 days) | 17 | 17 |
| Completed | 17 | 16 |
| Not completed | 2 | 4 |
Percentage of participants that complete all study activities and follow-up through 90 days
| Participants | Fixed Duration Treatment | Patient-directed Antimicrobial Duration (PDAD) |
|---|---|---|
| Feasibility of Completing All Clinical Trial Activities and Follow-up | 17 | 16 |
Participant does not require any additional antimicrobial treatment and they do not have a recurrence of symptoms after initial clinical improvement.
| Participants | Fixed Duration Treatment | Patient-directed Antimicrobial Duration (PDAD) |
|---|---|---|
| Sustained Clinical Cure | 14 | 16 |
The bacterial pathogen found at trial entry is sustained to fewer than 1000 CFU/mL.
| Participants | Fixed Duration Treatment | Patient-directed Antimicrobial Duration (PDAD) |
|---|---|---|
| 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 | 11 |
Participant 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.
| Participants | Fixed Duration Treatment | Patient-directed Antimicrobial Duration (PDAD) |
|---|---|---|
| Clinical Cure Rate at the End of Treatment | 15 | 17 |
| Participants | Fixed Duration Treatment | Patient-directed Antimicrobial Duration (PDAD) |
|---|---|---|
| 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 | 11 |
| Participants | Fixed Duration Treatment | Patient-directed Antimicrobial Duration (PDAD) |
|---|---|---|
| Additional Health Care Visits With the Chief Complaint of Urinary Tract Infection | 1 | 0 |
Collected over 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fixed Duration Treatment | 0/19 (0%) | 0/19 (0%) | 7/19 (36.8%) |
| Patient-directed Antimicrobial Duration (PDAD) | 0/20 (0%) | 0/20 (0%) | 7/20 (35%) |
| Event | Fixed Duration Treatment | Patient-directed Antimicrobial Duration (PDAD) |
|---|---|---|
| NauseaGastrointestinal disorders | 3/19 | 0/20 |
| DiarrheaGastrointestinal disorders | 1/19 | 3/20 |
| Yeast InfectionInfections and infestations | 2/19 | 1/20 |
| Burning/Itching/Pain in vaginal areaReproductive system and breast disorders | 2/19 | 2/20 |
| Abdominal PainGastrointestinal disorders | 1/19 | 2/20 |
| HeadacheNervous system disorders | 1/19 | 0/20 |
| FatigueNervous system disorders | 1/19 | 0/20 |
| HivesImmune system disorders | 0/19 | 1/20 |
| VomitingGastrointestinal disorders | 0/19 | 1/20 |
| Age, Continuous(Years) | Fixed Duration Treatment | Patient-directed Antimicrobial Duration (PDAD) | Total |
|---|---|---|---|
| Median | 35 (18 to 58) | 31 (18 to 58) | 32 (25 to 45) |
| Sex: Female, Male(Participants) | Fixed Duration Treatment | Patient-directed Antimicrobial Duration (PDAD) | Total |
|---|---|---|---|
| Female | 19 | 20 | 39 |
| Male | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | Fixed Duration Treatment | Patient-directed Antimicrobial Duration (PDAD) | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Brett A Faine