Patient-Directed Antimicrobial Duration in Acute Uncomplicated Pyelonephritis

• Status: Recruiting
• Trial end date: 2025-01-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Brett A Faine
• Collaborator: University of California, Los Angeles
• Treatments: Cephalexin

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