Status:
COMPLETED
Febrile Urinary Tract Infection Randomized Short Treatment Trial
Lead Sponsor:
Leiden University Medical Center
Collaborating Sponsors:
Bronovo Hospital
Medical Center Haaglanden
Conditions:
Urinary Tract Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 unselec...
Detailed Description
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 popula...
Eligibility Criteria
Inclusion
- Competent patient aged 18 years or above
- One or more symptom(s) suggestive of urinary tract infection (dysuria, frequency or urgency\*; perineal or suprapubic pain; costo-vertebral tenderness or flank pain)
- 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
- Positive urine nitrate test and/or leucocyturia as depicted by positive leukocyte esterase test or microscopy
Exclusion
- Known allergy to fluoroquinolones
- Female patients who are pregnant or lactating
- Patients with known polycystic kidney disease
- Patients on permanent renal replacement therapy (hemodialysis or peritoneal dialysis)
- Patients with history of kidney transplantation
- Residence outside country of enrolment
- Inability to speak or read Dutch
- Isolated causal uropathogen resistant to ciprofloxacin
- Renal abscess
- Chronic bacterial prostatitis
- Suspicion or evidence of any metastatic infectious foci
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00809913
Start Date
December 1 2008
End Date
September 1 2013
Last Update
September 16 2016
Active Locations (6)
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1
Groene Hart Hospital
Gouda, Netherlands, 2800 BB
2
Leiden University Medical Center
Leiden, Netherlands, 2300 RC
3
Alrijne Hospital
Leiden, Netherlands, 2334 CK
4
Alrijne Hospital
Leiderdorp, Netherlands, 2350 CC