Pyelonephritis Acute
Conditions
Keywords
cephalexin
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 objectives of this pilot trial are to determine the feasibility and safety of conducting a full-scale multi-center randomized controlled trial.
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 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.
Interventions
DRUGCephalexin
Cephalexin 1000 mg by mouth 3 times daily for 10 days
DRUGCephalexin or placebo
Cephalexin 1000 mg by mouth 3 times daily for a minimum of 3 days, once participant reports symptom resolution for 24 hours they will switch to placebo for remainder of 10 days of treatment.
Sponsors
Brett A Faine
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Completing All Clinical Trial Activities and Follow-up | 90 days | Percentage of participants that complete all study activities and follow-up through 90 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sustained Clinical Cure | 30 days | Participant does not require any additional antimicrobial treatment and they do not have a recurrence of symptoms after initial clinical improvement. |
| Sustained Microbiological Cure Defined as the Bacterial Pathogen Found at Trial Entry is Reduced to Fewer Than 10^3 Cfu/mL and no New Pathogen >10^3 Cfu/mL, | 30 days | The bacterial pathogen found at trial entry is sustained to fewer than 1000 CFU/mL. |
| Clinical Cure Rate at the End of Treatment | 15-21 days | Participant does not require any additional antimicrobial treatment and they do not have a recurrence of symptoms after initial clinical improvement AND the bacterial pathogen found at trial entry is reduced to fewer than 1000 CFU/mL. |
| Microbiological Cure Rate at End of Treatment Defined as Defined as the Bacterial Pathogen Found at Trial Entry is Reduced to Fewer Than 10^3 Cfu/mL and no New Pathogen >10^3 Cfu/mL, | Day 15-21 | — |
| Additional Health Care Visits With the Chief Complaint of Urinary Tract Infection | 90 days | — |
Countries
United States
Participant flow
Recruitment details
We conducted a double-blind, pilot randomized trial at three U.S. emergency departments (EDs) at academic medical centers from 2024-25.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 32 Years |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 20 |
| other Total, other adverse events | 7 / 19 | 7 / 20 |
| serious Total, serious adverse events | 0 / 19 | 0 / 20 |
Outcome results
None listed