Patient-Directed Antimicrobial Duration in Acute Uncomplicated Pyelonephritis

Brett A Faine

Status and phase

Enrolling

Phase 4

Conditions

Pyelonephritis Acute

Treatments

Drug: Cephalexin or placebo

Drug: Cephalexin

Study type

Interventional

Funder types

Other

Identifiers

NCT06127160

202303721

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

Female

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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