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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
35
Cephalexin 1000 mg by mouth 3 times daily for 10 days
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.
Olive View - UCLA Medical Center
Sylmar, California, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Feasibility of completing all clinical trial activities and follow-up
Percentage of participants that complete all study activities and follow-up through 90 days
Time frame: 90 days
Sustained clinical cure
Participant does not require any additional antimicrobial treatment and they do not have a recurrence of symptoms after initial clinical improvement.
Time frame: 30 days
Sustained microbiological cure
The bacterial pathogen found at trial entry is sustained to fewer than 1000 CFU/mL.
Time frame: 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.
Time frame: 15-21 days
Adverse event and side effect event rates
Time frame: 30 days
Additional health care visits with the chief complaint of urinary tract infection
Time frame: 30 days
Time to return to normal activities
Time frame: 30 days
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