Urinary Tract Infection (UTI) Urological and Genital Diseases Urinary tract infection, site not specified
Conditions
Interventions
Duration of antibiotic therapy will be based on guidelines (control group) or guided by diagnosis-specific PCT and pyuria cut-off ranges (PCT-Pyuria group).
All patients will receive a guideline-bas
Sponsors
Kantonsspital Aarau (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients 18 years of age or older 2. Admitted from the community or a nursing home with acute (i.e. symptoms less than 28 days) UTI as one main diagnosis based on at least one clinical symptom (core body temperature >= 38.0° C, urgency, frequency of micturition, dysuria, suprapubic pain, flank pain, costovertebral angle tenderness, nausea and vomiting) 3. One urinary criterion (pyuria (>20 leukocytes/µl), and/or nitrites) in patients without antibiotic pretreatment. If the initial and final diagnoses are discrepant, the patient will be classified according to the final diagnosis. If the final diagnosis is different from an UTI, the patient will be classified as ?others?. 4. Ability to understand verbal and written instructions and informed consent by patient or available relatives. If both the patient is unable to provide informed consent (e.g. dementia, coma) and there are no relatives available, an independent physician, who is not involved in the trial, may provide the informed consent based on the presumed will of the patient.
Exclusion criteria
Exclusion criteria: 1. Pregnancy 2. Immundeficiency (neutrophiles 4, or PSA more than double of a pre-existing baseline level, or pain on palpation) 4. Implanted foreign bodies in the urinary tract or urinary catheters 5. Patients with endovascular prostheses or foreign bodies 6. Patients with non-endovascular prostheses or foreign bodies within 6 months after implantation 7. Pre-treatment with antibiotics within the last 48 hours 8. Patients without command of the German (or other local) language, who will not be able within reason to get translation (e.g. family members) during admission, hospitalization and follow-up telephone interview 9. Terminal and very severe disease or medical co-morbidity where death is imminent and comfort therapy is provided 10. Foreseeable non-compliance for follow-up (e.g. current drug abuse)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Duration of antibiotic therapy (Antibiotic therapy study) 2. Physician-led length of stay during the index hospital exposure (triage study) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Analyzing the efficacy and safety of a PCT- and pyuria-guided antibiotic therapy to individualize and reduce antibiotic duration compared to guidelines. 1.1 Clinical and microbiological cure 7 days after end of therapy 1.2 30 day rate of clinical and microbiological recurrence 1.3 90 day rate of clinical recurrence 1.4 Antibiotic associated side effects 1.5 Relationship of pyuria, urine culture cut-offs and urinary á1-microglobulin/creatinine ratio with presence of pyelonephritis and level of biomarkers (CRP, PCT, ProADM, and other biomarkers such as urea, natriuretic peptides (ANP, BNP), copeptin, endothelin, apoprotein A1). 1.6 Correlation between sonographic signs of pyelonephritis and diagnosis based on urine culture cut-offs, clinical criteria and biomarkers. 2. Testing the impact of ProADM-enhanced triage decisions compared to standard of care, both in high-intensity implementation of interdisciplinary risk assessment for triage in patients with UTIs presenting to an ED on length of stay, regarding: 2.1. Other measures of resource utilization (different definitions of length of stay including rehospitalisation; treatment changes) 2.2. Adherence to triage algorithms 2.3. Functional status and adverse events (i.e. mortality; rate of complications) 2.4. Patient satisfaction 2.5. Quality of life assessment 2.6. Effective and chargeable costs for treatment path. Endpoints will be assessed at discharge to non-hospital setting, 30 days and 90 days after admission. | — |
Countries
Switzerland
Outcome results
None listed