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Clinical Trial 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT06127160
Study type Interventional
Source University of Iowa
Contact Brett Faine, PharmD
Phone +1 319 356 2577
Email brett-faine@uiowa.edu
Status Not yet recruiting
Phase Phase 4
Start date June 2024
Completion date January 31, 2025

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