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)

Phase 4

Completed

Conditions: febrile urinary tract infection or pyelonephritis
10004018
10046590

Registration Number: NL-OMON39150

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 500

Inclusion Criteria

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

Exclusion Criteria

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 replacement 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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The clinical cure rate through the 10- to 18-day posttherapy visit. Clinical<br /><br>cure is defined as the resolution of fever and signs and symptoms of UTI. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>This includes microbiological cure rate 10- to 18-day posttherapy, 30- and 90-<br /><br>day overall mortality rate, clinical cure rate 70- to 84- day posttherapy, time<br /><br>to resolution of symptoms, relapse rate of UTI, adverse events or<br /><br>complications, rate of pelvic floor dysfunction, occurrence of CDAD. The course<br /><br>and predictive value of clinical parameters and biomarkers in blood and urine.</p><br>