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Patient-Directed Antimicrobial Duration in Acute Uncomplicated Pyelonephritis

Sponsor
Brett A Faine (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06127160
Collaborator
University of California, Los Angeles (Other)
40
Enrollment
2
Arms
24
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Personalized Antibiotic Treatment in the Emergency Department: Panther Trial
Anticipated Study Start Date :
Jan 1, 2024
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jan 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Standard Duration Treatment

Drug: Cephalexin
Cephalexin 1000 mg by mouth 3 times daily for 10 days
Experimental: Patient-directed antimicrobial duration (PDAD)

Drug: Cephalexin 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.

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. 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.

  2. Sustained microbiological cure [30 days]

    The bacterial pathogen found at trial entry is sustained to fewer than 1000 CFU/mL.

  3. Clinical and microbiological cure rates after 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.

  4. Adverse event and side effect event rates [30 days]

  5. Additional health care visits with the chief complaint of urinary tract infection [30 days]

  6. Time to return to normal activities [30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Brett A Faine
  • University of California, Los Angeles

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Brett A Faine, Clinical Associate Professor, University of Iowa
ClinicalTrials.gov Identifier:
NCT06127160
Other Study ID Numbers:
  • 202303721
First Posted:
Nov 13, 2023
Last Update Posted:
Nov 13, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Brett A Faine, Clinical Associate Professor, University of Iowa
cephalexin
Additional relevant MeSH terms:
Pyelonephritis
Cephalexin

Study Results

No Results Posted as of Nov 13, 2023