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Completed
NCT06127160
Patient-Directed Antimicrobial Duration in Acute Uncomplicated Pyelonephritis
Conditions: Pyelonephritis Acute
Sex: Female
Ages: 18 Years – 55 Years
Healthy volunteers: Yes
Phase: PHASE4
Enrollment: 39
Sponsor: Brett A Faine
Location: Olive View - UCLA Medical Center Sylmar California
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.
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 \
Source: ClinicalTrials.gov (NCT06127160). StuddyBuddy aggregates publicly available trial information.