Pyelonephritis AcutePhase 4NCT06127160

Patient-Directed Antimicrobial Duration in Acute Uncomplicated Pyelonephritis

A Phase 4 study testing Cephalexin in people with Pyelonephritis Acute, run by Brett A Faine at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 55 years, women onlyHealthy volunteers can take part
Conditions the study is for: Pyelonephritis Acute
What is being tested?: Cephalexin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 39 participants
Where: 2 sitesUnited States
Study dates: 4 Jun 2024to 29 Aug 2025
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Females between 18 and 55 years of age
Diagnosis of acute uncomplicated pyelonephritis
Can be discharged home on oral antimicrobial treatment
Ability to provide written informed consent in English or Spanish

Who cannot join

Took antibiotics in the prior 48 hours
Insulin-dependent diabetes
End-stage liver disease
If the patient reports a penicillin allergy, and is deemed to be high-risk using the penicillin allergy clinical decision rule (PEN-FAST)
Serious allergy (e.g., angioedema, anaphylaxis) to the study medication or a similarly reported allergy to a cephalosporin
Known or identified hydronephrosis, obstruction, or abscess identified by emergency department ultrasound

Show all 13Show fewer

Presence of a kidney stone
Pregnancy or lactation
Renal dysfunction (defined as creatinine clearance of less than 30 mL/min)
Renal transplantation
Complicated pyelonephritis (defined anatomical or functional abnormality of the urinary tract that predisposes to infection)
Need for additional antimicrobial therapy for a coexisting infection
Human immunodeficiency virus (HIV) infection, with either a recent (in the past 6 months) acquired immune deficiency syndrome-defining condition or a cluster of differentiation-4 (CD-4+) T lymphocyte count <200/mm^3

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Olive View - UCLA Medical Center
Sylmar, California, 91342

Other trials in United States

About this study

Official title: Personalized Antibiotic Treatment in the Emergency Department: Panther Trial

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.

Read the detailed description

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.

Conditions: Pyelonephritis Acute
Being tested: Cephalexin, Cephalexin or placebo
Keywords: cephalexin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CephalexinDrug
Cephalexin 1000 mg by mouth 3 times daily for 10 days
Cephalexin or placeboDrug
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.

Study groups in NCT06127160
Study group	Role	What they receive
Standard Duration Treatment	Active comparator	Not described Receives: Drug: Cephalexin
Patient-directed antimicrobial duration (PDAD)	Experimental	Not described Receives: Drug: Cephalexin or placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility of Completing All Clinical Trial Activities and Follow-up
Percentage of participants that complete all study activities and follow-up through 90 days
Measured: 90 days

Secondary outcomes (5)

Sustained Clinical Cure
Participant does not require any additional antimicrobial treatment and they do not have a recurrence of symptoms after initial clinical improvement.
Measured: 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.
Measured: 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.
Measured: 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,
Measured: Day 15-21
Additional Health Care Visits With the Chief Complaint of Urinary Tract Infection
Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Jun 202429 Aug 2025

First posted13 Nov 2023
Study start4 Jun 2024
Primary completion29 Aug 2025
Study completion29 Aug 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (20)Papers the sponsor has linked to this study.
Other trials for Pyelonephritis AcuteStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06127160
Sponsor's protocol ID: 202303721
Status last verified: Jul 2026
First submitted: 31 Oct 2023
Last updated: 3 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Foxman B. The epidemiology of urinary tract infection. Nat Rev Urol. 2010 Dec;7(12):653-60. doi: 10.1038/nrurol.2010.190.
PubMed 21139641
Foxman B. Urinary tract infection syndromes: occurrence, recurrence, bacteriology, risk factors, and disease burden. Infect Dis Clin North Am. 2014 Mar;28(1):1-13. doi: 10.1016/j.idc.2013.09.003. Epub 2013 Dec 8.
PubMed 24484571
Taylor RA, Moore CL, Cheung KH, Brandt C. Predicting urinary tract infections in the emergency department with machine learning. PLoS One. 2018 Mar 7;13(3):e0194085. doi: 10.1371/journal.pone.0194085. eCollection 2018.
PubMed 29513742
Hicks LA, Bartoces MG, Roberts RM, Suda KJ, Hunkler RJ, Taylor TH Jr, Schrag SJ. US outpatient antibiotic prescribing variation according to geography, patient population, and provider specialty in 2011. Clin Infect Dis. 2015 May 1;60(9):1308-16. doi: 10.1093/cid/civ076. Epub 2015 Mar 5.
PubMed 25747410
May L, Cosgrove S, L'Archeveque M, Talan DA, Payne P, Jordan J, Rothman RE. A call to action for antimicrobial stewardship in the emergency department: approaches and strategies. Ann Emerg Med. 2013 Jul;62(1):69-77.e2. doi: 10.1016/j.annemergmed.2012.09.002. Epub 2012 Nov 2.
PubMed 23122955
Flores-Mireles AL, Walker JN, Caparon M, Hultgren SJ. Urinary tract infections: epidemiology, mechanisms of infection and treatment options. Nat Rev Microbiol. 2015 May;13(5):269-84. doi: 10.1038/nrmicro3432. Epub 2015 Apr 8.
PubMed 25853778
Gupta K, Hooton TM, Naber KG, Wullt B, Colgan R, Miller LG, Moran GJ, Nicolle LE, Raz R, Schaeffer AJ, Soper DE; Infectious Diseases Society of America; European Society for Microbiology and Infectious Diseases. International clinical practice guidelines for the treatment of acute uncomplicated cystitis and pyelonephritis in women: A 2010 update by the Infectious Diseases Society of America and the European Society for Microbiology and Infectious Diseases. Clin Infect Dis. 2011 Mar 1;52(5):e103-20. doi: 10.1093/cid/ciq257.
PubMed 21292654
Talan DA, Takhar SS, Krishnadasan A, Abrahamian FM, Mower WR, Moran GJ; EMERGEncy ID Net Study Group. Fluoroquinolone-Resistant and Extended-Spectrum beta-Lactamase-Producing Escherichia coli Infections in Patients with Pyelonephritis, United States(1). Emerg Infect Dis. 2016 Sep;22(9):1594-603. doi: 10.3201/eid2209.160148.
PubMed 27532362
Talan DA, Takhar SS, Krishnadasan A, Mower WR, Pallin DJ, Garg M, Femling J, Rothman RE, Moore JC, Jones AE, Lovecchio F, Jui J, Steele MT, Stubbs AM, Chiang WK, Moran GJ. Emergence of Extended-Spectrum beta-Lactamase Urinary Tract Infections Among Hospitalized Emergency Department Patients in the United States. Ann Emerg Med. 2021 Jan;77(1):32-43. doi: 10.1016/j.annemergmed.2020.08.022. Epub 2020 Oct 31.
PubMed 33131912
Low M, Neuberger A, Hooton TM, Green MS, Raz R, Balicer RD, Almog R. Association between urinary community-acquired fluoroquinolone-resistant Escherichia coli and neighbourhood antibiotic consumption: a population-based case-control study. Lancet Infect Dis. 2019 Apr;19(4):419-428. doi: 10.1016/S1473-3099(18)30676-5. Epub 2019 Mar 4.
PubMed 30846277
Brown KA, Khanafer N, Daneman N, Fisman DN. Meta-analysis of antibiotics and the risk of community-associated Clostridium difficile infection. Antimicrob Agents Chemother. 2013 May;57(5):2326-32. doi: 10.1128/AAC.02176-12. Epub 2013 Mar 11.
PubMed 23478961
McCusker ME, Harris AD, Perencevich E, Roghmann MC. Fluoroquinolone use and Clostridium difficile-associated diarrhea. Emerg Infect Dis. 2003 Jun;9(6):730-3. doi: 10.3201/eid0906.020385.
PubMed 12781017
Sader HS, Biedenbach DJ, Streit JM, Jones RN. Cefdinir activity against contemporary North American isolates from community-acquired urinary tract infections. Int J Antimicrob Agents. 2005 Jan;25(1):89-92. doi: 10.1016/j.ijantimicag.2004.07.006.
PubMed 15620832
Mogle BT, Beccari MV, Steele JM, Fazili T, Kufel WD. Clinical considerations for oral beta-lactams as step-down therapy for Enterobacteriaceae bloodstream infections. Expert Opin Pharmacother. 2019 Jun;20(8):903-907. doi: 10.1080/14656566.2019.1594774. Epub 2019 Mar 25. No abstract available.
PubMed 30908107
Fung-Tomc JC, Huczko E, Stickle T, Minassian B, Kolek B, Denbleyker K, Bonner D, Kessler R. Antibacterial activities of cefprozil compared with those of 13 oral cephems and 3 macrolides. Antimicrob Agents Chemother. 1995 Feb;39(2):533-8. doi: 10.1128/AAC.39.2.533.
PubMed 7726528

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Real-World Study of Obstructive Upper Urinary Tract Stones and Acute Pyelonephritis
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All Pyelonephritis Acute trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Personalized Antibiotic Treatment in the Emergency Department: Panther Trial
ClinicalTrials.gov ID: NCT06127160
Acronym / sponsor ID: 202303721
Conditions: Pyelonephritis Acute
Keywords: cephalexin
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: Brett A FaineUniversity, hospital or other
Collaborators: University of California, Los Angeles
Study start: 4 Jun 2024 (actual)
Primary completion: 29 Aug 2025 (actual)
Study completion: 29 Aug 2025 (actual)
First posted: 13 Nov 2023 (actual)
Results: Posted 3 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2

Arm	Type	Receives
Standard Duration Treatment	Active comparator	Drug: Cephalexin
Patient-directed antimicrobial duration (PDAD)	Experimental	Drug: Cephalexin or placebo

Who may qualify

Ages: 18 to 55 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Females between 18 and 55 years of age
Diagnosis of acute uncomplicated pyelonephritis
Can be discharged home on oral antimicrobial treatment
Ability to provide written informed consent in English or Spanish

Key exclusion criteria (13 listed)

Took antibiotics in the prior 48 hours
Insulin-dependent diabetes
End-stage liver disease
If the patient reports a penicillin allergy, and is deemed to be high-risk using the penicillin allergy clinical decision rule (PEN-FAST)
Serious allergy (e.g., angioedema, anaphylaxis) to the study medication or a similarly reported allergy to a cephalosporin

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CephalexinCephalexin 1000 mg by mouth 3 times daily for 10 days	Drug	Standard Duration Treatment
Cephalexin or placeboCephalexin 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.	Drug	Patient-directed antimicrobial duration (PDAD)

Primary outcome

Feasibility of Completing All Clinical Trial Activities and Follow-up
Time frame: 90 days
Percentage of participants that complete all study activities and follow-up through 90 days

5 secondary outcomes

Sustained Clinical Cure
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,
Time frame: 30 days
Clinical Cure Rate at the End of Treatment
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

Results and safety

Results posted to the registry on 3 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fixed Duration Treatment	19	17
Patient-directed Antimicrobial Duration (PDAD)	20	16

Primary outcome: Feasibility of Completing All Clinical Trial Activities and Follow-up

Time frame: 90 days. Count of participants. Unit: Participants

Measure	Fixed Duration Treatment n = 17	Patient-directed Antimicrobial Duration (PDAD) n = 16
Value	17	16

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 30 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fixed Duration Treatment	0 of 19 (0%)	7 of 19 (36.8%)	0 of 19
Patient-directed Antimicrobial Duration (PDAD)	0 of 20 (0%)	7 of 20 (35%)	0 of 20

Limitations and caveats (from the sponsor): 1. This was a pilot RCT designed to establish feasibility of conducing a larger trial and detect major safety concerns and was not powered to test non-inferiority or detect meaningful differences in clinical and AE outcomes. 2. Baseline urine cultures were frequently contaminated, precluding evaluation of microbiologic outcomes for all enrolled participants.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21139641Foxman B. The epidemiology of urinary tract infection. Nat Rev Urol. 2010 Dec;7(12):653-60. doi: 10.1038/nrurol.2010.190.
Background: PubMed 24484571Foxman B. Urinary tract infection syndromes: occurrence, recurrence, bacteriology, risk factors, and disease burden. Infect Dis Clin North Am. 2014 Mar;28(1):1-13. doi: 10.1016/j.idc.2013.09.003. Epub 2013 Dec 8.
Background: PubMed 29513742Taylor RA, Moore CL, Cheung KH, Brandt C. Predicting urinary tract infections in the emergency department with machine learning. PLoS One. 2018 Mar 7;13(3):e0194085. doi: 10.1371/journal.pone.0194085. eCollection 2018.
Background: PubMed 25747410Hicks LA, Bartoces MG, Roberts RM, Suda KJ, Hunkler RJ, Taylor TH Jr, Schrag SJ. US outpatient antibiotic prescribing variation according to geography, patient population, and provider specialty in 2011. Clin Infect Dis. 2015 May 1;60(9):1308-16. doi: 10.1093/cid/civ076. Epub 2015 Mar 5.
Background: PubMed 23122955May L, Cosgrove S, L'Archeveque M, Talan DA, Payne P, Jordan J, Rothman RE. A call to action for antimicrobial stewardship in the emergency department: approaches and strategies. Ann Emerg Med. 2013 Jul;62(1):69-77.e2. doi: 10.1016/j.annemergmed.2012.09.002. Epub 2012 Nov 2.
Background: PubMed 25853778Flores-Mireles AL, Walker JN, Caparon M, Hultgren SJ. Urinary tract infections: epidemiology, mechanisms of infection and treatment options. Nat Rev Microbiol. 2015 May;13(5):269-84. doi: 10.1038/nrmicro3432. Epub 2015 Apr 8.
Background: PubMed 21292654Gupta K, Hooton TM, Naber KG, Wullt B, Colgan R, Miller LG, Moran GJ, Nicolle LE, Raz R, Schaeffer AJ, Soper DE; Infectious Diseases Society of America; European Society for Microbiology and Infectious Diseases. International clinical practice guidelines for the treatment of acute uncomplicated cystitis and pyelonephritis in women: A 2010 update by the Infectious Diseases Society of America and the European Society for Microbiology and Infectious Diseases. Clin Infect Dis. 2011 Mar 1;52(5):e103-20. doi: 10.1093/cid/ciq257.
Background: PubMed 27532362Talan DA, Takhar SS, Krishnadasan A, Abrahamian FM, Mower WR, Moran GJ; EMERGEncy ID Net Study Group. Fluoroquinolone-Resistant and Extended-Spectrum beta-Lactamase-Producing Escherichia coli Infections in Patients with Pyelonephritis, United States(1). Emerg Infect Dis. 2016 Sep;22(9):1594-603. doi: 10.3201/eid2209.160148.
Background: PubMed 33131912Talan DA, Takhar SS, Krishnadasan A, Mower WR, Pallin DJ, Garg M, Femling J, Rothman RE, Moore JC, Jones AE, Lovecchio F, Jui J, Steele MT, Stubbs AM, Chiang WK, Moran GJ. Emergence of Extended-Spectrum beta-Lactamase Urinary Tract Infections Among Hospitalized Emergency Department Patients in the United States. Ann Emerg Med. 2021 Jan;77(1):32-43. doi: 10.1016/j.annemergmed.2020.08.022. Epub 2020 Oct 31.
Background: PubMed 30846277Low M, Neuberger A, Hooton TM, Green MS, Raz R, Balicer RD, Almog R. Association between urinary community-acquired fluoroquinolone-resistant Escherichia coli and neighbourhood antibiotic consumption: a population-based case-control study. Lancet Infect Dis. 2019 Apr;19(4):419-428. doi: 10.1016/S1473-3099(18)30676-5. Epub 2019 Mar 4.
Background: PubMed 23478961Brown KA, Khanafer N, Daneman N, Fisman DN. Meta-analysis of antibiotics and the risk of community-associated Clostridium difficile infection. Antimicrob Agents Chemother. 2013 May;57(5):2326-32. doi: 10.1128/AAC.02176-12. Epub 2013 Mar 11.
Background: PubMed 12781017McCusker ME, Harris AD, Perencevich E, Roghmann MC. Fluoroquinolone use and Clostridium difficile-associated diarrhea. Emerg Infect Dis. 2003 Jun;9(6):730-3. doi: 10.3201/eid0906.020385.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cephalexin in people with Pyelonephritis Acute, run by Brett A Faine at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of Completing All Clinical Trial Activities and Follow-up (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06127160, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.