Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-25 @ 2:04 AM
NCT ID:
NCT06127160
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
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06127160
Study Brief:
Protocol Section:
NCT06127160