Patient-Directed Antimicrobial Duration in Acute Uncomplicated Pyelonephritis

September 5, 2025 updated by: Brett A Faine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion:

  • 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

Exclusion:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Duration Treatment
Drug: Cephalexin
Cephalexin 1000 mg by mouth 3 times daily for 10 days
Experimental: Patient-directed antimicrobial duration (PDAD)
Drug: Cephalexin or placebo
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained clinical cure
Time Frame: 30 days
Participant does not require any additional antimicrobial treatment and they do not have a recurrence of symptoms after initial clinical improvement.
30 days
Sustained microbiological cure
Time Frame: 30 days
The bacterial pathogen found at trial entry is sustained to fewer than 1000 CFU/mL.
30 days
Clinical and microbiological cure rates after the end of treatment
Time Frame: 15-21 days
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.
15-21 days
Adverse event and side effect event rates
Time Frame: 30 days
30 days
Additional health care visits with the chief complaint of urinary tract infection
Time Frame: 30 days
30 days
Time to return to normal activities
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brett A Faine

Collaborators

University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 4, 2024

Primary Completion (Actual)

August 29, 2025

Study Completion (Actual)

August 29, 2025

Study Registration Dates

First Submitted

October 31, 2023

First Submitted That Met QC Criteria

November 6, 2023

First Posted (Actual)

November 13, 2023

Study Record Updates

Last Update Posted (Estimated)

September 12, 2025

Last Update Submitted That Met QC Criteria

September 5, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202303721

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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