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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 \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06127160). StuddyBuddy aggregates publicly available trial information.