Status:
COMPLETED
Patient-Directed Antimicrobial Duration in Acute Uncomplicated Pyelonephritis
Lead Sponsor:
Brett A Faine
Collaborating Sponsors:
University of California, Los Angeles
Conditions:
Pyelonephritis Acute
Eligibility:
FEMALE
18-55 years
Phase:
PHASE4
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 ob...
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 resolutio...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2025
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT06127160
Start Date
June 4 2024
End Date
August 29 2025
Last Update
September 12 2025
Active Locations (2)
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1
Olive View - UCLA Medical Center
Sylmar, California, United States, 91342
2
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242