Patient-directed treatment duration for acute pyelonephritis
Personalized Antibiotic Treatment in the Emergency Department: Panther Trial
This study is testing if letting women with acute pyelonephritis choose how long to take their antibiotic can be safe and effective compared to the usual 10-day treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | University of Iowa Academic / other |
| Locations | 2 sites (Sylmar, California and 1 other locations) |
| Trial ID | NCT06127160 on ClinicalTrials.gov |
What this trial studies
This pilot study randomizes 40 female patients with acute uncomplicated pyelonephritis to receive either a standard 10-day course of cephalexin or a patient-directed antimicrobial duration (PDAD) approach. Patients in the PDAD group will take cephalexin for a minimum of 3 days and switch to placebo once they report 24 hours of symptom resolution. The study will assess feasibility and safety through daily evaluations using a mobile application and urine sample collections at specified intervals. The primary goal is to determine the viability of conducting a larger multi-center randomized controlled trial based on the findings.
Who should consider this trial
Good fit: Ideal candidates are females aged 18 to 55 diagnosed with acute uncomplicated pyelonephritis who can be treated with oral antibiotics.
Not a fit: Patients with complicated pyelonephritis, significant allergies to cephalosporins, or other serious medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could empower patients to manage their treatment duration, potentially leading to improved outcomes and reduced antibiotic use.
How similar studies have performed: While this approach is innovative, similar studies exploring patient-directed treatment durations have shown promise in other conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Sylmar, California and 1 other locations
- Olive View - UCLA Medical Center — Sylmar, California, United States (Recruiting)
- University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States (Recruiting)
Study contacts
- Study coordinator: Brett Faine, PharmD
- Email: brett-faine@uiowa.edu
- Phone: +1 319 356 2577
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.