Relevance of Biomarkers and Clinical Predictors of Outcome in Unselected Population with Febrile Urinary Tract Infection at Primary Care and Emergency Department in a Prospective, Randomized Cohort Trial Comparing Short (7 days) Antibiotic Treatment with Conventional Treatment (14 days) - FUTIRST (Febrile Urinary Tract Infection Randomized Short Treatment)
- Conditions
- To determine whether a 7-day duration of antibiotic treatment is non inferior to 14-day standard duration of treatment in adults presenting at primary care or emergency department with febrile urinary tract infection.
- Registration Number
- EUCTR2008-001081-80-NL
- Lead Sponsor
- eiden University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 500
1.Competent patient aged 18 years or above
2.One or more symptom(s) suggestive of urinary tract infection (dysuria, frequency or urgency*; perineal or suprapubic pain; costo-vertebral tenderness or flank pain)
3.Fever (ear or rectal temp of 38.2 oC or higher, or axillary temp of 38 oC or higher), or history of feeling feverish with shivering or rigors in the past 24 hours
4.Positive urine nitrate test and/or leucocyturia as depicted by positive leukocyte esterase test or microscopy
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.Known allergy to fluoroquinolones
2.Female patients who are pregnant or lactating
3.Patients with known polycystic kidney disease
4.Patients on permanent renal replacememt therapy (hemodialysis or peritoneal dialysis)
5.Patients with history of kidney transplantation
6.Residence outside country of enrolment
7.Inability to speak or read Dutch
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method