Patient-Directed Antimicrobial Duration in Acute Uncomplicated Pyelonephritis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Personalized Antibiotic Treatment in the Emergency Department: Panther Trial

Conditions
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Pyelonephritis Acute

Intervention / Treatment
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* Drug: Cephalexin
* Drug: Cephalexin or placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Duration Treatment<br> | Drug: Cephalexin<br>* Cephalexin 1000 mg by mouth 3 times daily for 10 days<br>|
| Experimental: Patient-directed antimicrobial duration (PDAD)<br> | Drug: Cephalexin or placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of completing all clinical trial activities and follow-up | Percentage of participants that complete all study activities and follow-up through 90 days | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained clinical cure | Participant does not require any additional antimicrobial treatment and they do not have a recurrence of symptoms after initial clinical improvement. | 30 days | 
| Sustained microbiological cure | The bacterial pathogen found at trial entry is sustained to fewer than 1000 CFU/mL. | 30 days | 
| Clinical and microbiological cure rates after the end of treatment | 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. | 15-21 days | 
| Adverse event and side effect event rates |  | 30 days | 
| Additional health care visits with the chief complaint of urinary tract infection |  | 30 days | 
| Time to return to normal activities |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cephalexin