Clinical Trials Logo

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 Recruiting
Phase Phase 4
Start date June 2024
Completion date January 31, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT03959163 - The Validity of the Quick Renal MRI in Pediatric Kidney Disease N/A
Suspended NCT05544565 - 3-day IV Antibiotic Treatment Versus 3-day IV Followed by 7-day Oral Antibiotic Treatment for AP in Children Phase 4
Completed NCT04651244 - Diagnostic Imaging of Acute Pyelonephritis
Completed NCT03179384 - Impact on the Intestinal Microbiota of Treatment With Ceftriaxone in Women's Acute Community Pyelonephritis Phase 4
Completed NCT04594161 - Effectiveness of Drainage by PCN vs. JJ in Patients With Symptoms of Obstructive Kidney Disease Caused by Urolithiasis N/A
Recruiting NCT05597540 - Efficacy of 7 Days Versus 14 Days of Antibiotic Therapy for Acute Pyelonephritis in Kidney Transplant Recipients, a Multicentre Randomized Non-inferiority Trial. Phase 3
Withdrawn NCT04700787 - Safety, Tolerability, and Pharmacokinetics of Sulopenem in Adolescents Phase 1