NCT06127160

Patient-Directed Antimicrobial Duration in Acute Uncomplicated Pyelonephritis

Personalized Antibiotic Treatment in the Emergency Department: Panther Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Brett A Faine · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

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

Interventions

Type	Name	Description
DRUG	Cephalexin	Cephalexin 1000 mg by mouth 3 times daily for 10 days
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.

Timeline

• Start date: 2024-06-04
• Primary completion: 2025-08-29
• Completion: 2025-08-29
• First posted: 2023-11-13
• Last updated: 2025-09-12

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study