Patient-Directed Antimicrobial Duration in Acute Uncomplicated Pyelonephritis

Phase 4

Recruiting

• Conditions: Pyelonephritis Acute
• Interventions: Drug: Cephalexin or placebo; Drug: Cephalexin

• Registration Number: NCT06127160
• Lead Sponsor: Brett A Faine

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.

Study Timeline

• Study First Submitted: 2023-10-31
• Study First Submitted QC: 2023-11-06
• Study First Posted: 2023-11-13
• Study Start: 2024-06-04
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-07
• Last Update Posted: 2024-08-09
• Primary Completion: 2024-12-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient-directed antimicrobial duration (PDAD)	Cephalexin or placebo	-
Standard Duration Treatment	Cephalexin	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Time to return to normal activities	30 days
Additional health care visits with the chief complaint of urinary tract infection	30 days
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	30 days	The bacterial pathogen found at trial entry is sustained to fewer than 1000 CFU/mL.
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.
Adverse event and side effect event rates	30 days

Trial Locations

Locations (2)

Olive View - UCLA Medical Center; 🇺🇸 Sylmar, California, United States

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States