Clinical trial NCT06127160: Patient-Directed Antimicrobial Duration in Acute Uncomplicated Pyelonephritis
Official title: Personalized Antibiotic Treatment in the Emergency Department: Panther Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Pyelonephritis Acute
Keywords: cephalexin
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
First posted: 2023-11-13
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Feasibility of completing all clinical trial activities and follow-up
timeFrame: 90 days
Secondary outcomes:
measure: Sustained clinical cure
timeFrame: 30 days
measure: Sustained microbiological cure
timeFrame: 30 days
measure: Clinical and microbiological cure rates after the end of treatment
timeFrame: 15-21 days
measure: Adverse event and side effect event rates
timeFrame: 30 days
measure: Additional health care visits with the chief complaint of urinary tract infection
timeFrame: 30 days
measure: Time to return to normal activities
timeFrame: 30 days
Other outcomes:
Locations:
city: Sylmar
country: United States
facility: Olive View - UCLA Medical Center
state: California
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
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