The purpose of this study is to determine whether a 7-day duration of antibiotic treatment of febrile urinary tract infection (FUTI) is non inferior to 14-day standard duration of treatment in unselected population presenting at primary care or emergency department.
In the last decades hospitalization rates of patients with acute pyelonephritis (AP) or FUTI has decreased from almost 100% to 10-30%. The outpatient management of patients with FUTI has become popular as well as oral antimicrobial treatment regiments and shortening of treatment duration. However, as such approaches are only discovered in otherwise young health non-pregnant women, the best management of FUTI in the elderly, men and patients with co-morbidity remains elusive. Bases on personal perception of the attending physician antibiotic treatment, duration varies approximately between 7-14 days. Facing the aging of the general population, it is urgent to better define the optimal treatment for AP or FUTI in an unselected population and to identify those at risk for treatment failure or poor outcome to guide and optimize individual patient management and to prevent on the one hand unnecessary long treatment duration and hospital admission and on the other hand unsafe short duration or unsafe outpatient management. In this study the efficacy and safety of a 7-day antimicrobial regimen compared to a 14-day antimicrobial regimen will be evaluated in an unselected population presenting with FUTI at primary care or emergency department. In addition a clinical and/or biomarker based scoring system of disease severity will be derived to predict those at risk for treatment failure or poor outcome.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
200
7 days of antibiotic treatment for febrile urinary tract infection / acute pyelonephritis compared to standard treatment of 14 days
Groene Hart Hospital
Gouda, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Alrijne Hospital
Leiden, Netherlands
Alrijne Hospital
Leiderdorp, Netherlands
Clinical cure rate through the 10- to 18-day posttherapy visit. Clinical cure is defined as the resolution of fever and signs and symptoms of UTI.
Time frame: 10-18 day posttherapy
Microbiological cure rate 10- to 18-day posttherapy
Time frame: 10-18 day posttherapy
All cause mortality
Time frame: 30 and 90 days
Clinical cure rate 70- to 84- day posttherapy
Time frame: 70-84 days posttherapy
Relapse rate of any urinary tract infection
Time frame: 90 days
Adverse events
Time frame: 90 days
Rate of pelvic floor dysfunction as assessed by standardized questionaire
Time frame: 10-18 days posttherapy
Occurence of Clostridium Difficile associated diarrhea
Time frame: 90 days
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Medical Center Haaglanden
The Hague, Netherlands
Bronovo Hospital
The Hague, Netherlands