Summary

Eligibility
for females ages 18-55 (full criteria)
Healthy Volunteers
healthy people welcome
Dates
study started
completion around

Description

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.

Official Title

Personalized Antibiotic Treatment in the Emergency Department: Panther Trial

Details

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.

Keywords

Pyelonephritis Acute, cephalexin, Pyelonephritis

Eligibility

For females ages 18-55

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/mm3

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Brett A Faine
Links
12. Food and Drug Administration. FDA updates warnings for fluoroquinolone antibiotics on risks of mental health and low blood sugar adverse reactions
ID
NCT06127160
Phase
Phase 4 Pyelonephritis Acute Research Study
Study Type
Interventional
Participants
Expecting 40 study participants
Last Updated