Patient-Directed Antimicrobial Duration in Acute Uncomplicated Pyelonephritis

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.

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.

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