Implementation of a clinical decision rule to optimize hospital admission policy of patients with febrile urinary tract infectio

Completed

Conditions: febrile urinary tract infection
pyelonephritis
10004018
10046590

Registration Number: NL-OMON41359

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 420

Inclusion Criteria

1. Competent patient aged 18 years or above
2. One or more symptom(s) suggestive of urinary tract infection (UTI) (dysuria, frequency or urgency; perineal or suprapubic pain; costovertebral tenderness or flank pain)
3. Fever (ear of rectal temperature of 38.2 oC or higher, or axillary temperature of 38.0 oC or higher), or a history of feeling feverish with shivering or rigors including the past 24 hours
4. Positive urine nitrate test and/or leukocyturia 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 known with 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 primary objective will be evaluated by primary and secondary outcome<br /><br>measures.<br /><br>The primary outcome measure are primary hospital admission rate (i.e. the<br /><br>percentage of patients presenting with FUTI at ED who will directly be admitted<br /><br>to hospital) and secondary hospital admission rate (i.e. the percentage of<br /><br>low-risk patients with PRACTICE < 100 points who need to be hospitalized after<br /><br>initial home-based treatment). The secondary outcome measures are 30- and<br /><br>90-day mortality rate, Intensive Care Unit (ICU) admission rate, the total<br /><br>number of hospitalization days over a 3-month follow-up and clinical- and<br /><br>microbiological cure rate.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcome will be evaluated from a 3-months perspective. Costs will<br /><br>include the time to assess the decision rule, primary and secondary<br /><br>hospitalization costs, extra costs of primary care and the costs of radiologic<br /><br>diagnostics (as home based management might also lead to reduction in<br /><br>radiologic evaluations to search for underlying urologic abnormalities).<br /><br>Patients* satisfaction with application of the PRACTICE will be evaluated soon<br /><br>after enrolment and 1 month thereafter. </p><br>