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ID
Source
Brief title
Health condition
Urinary tract infection, asymptomatic bacteriuria
Sponsors and support
Intervention
Outcome measures
Primary outcome
Biomarker levels (sensitivity, specificity, negative and positive predictive value) in women with and without UTI (including ASB)
Secondary outcome
Biomarker levels in women with upper versus lower UTI
Background summary
In community-dwelling elderly, the incidence of urinary tract infection (UTI) is higher for women than men, and increases significantly with age. Moreover, UTI is the most common infection in Dutch long-term care facilities (LTCF). Due to the high prevalence of asymptomatic bacteriuria (ASB) in elderly women (25-50%), the positive predictive value of pyuria and a positive urine culture is very low. Therefore, current guidelines require the presence of UTI-specific symptoms for antibiotic treatment. However, communication of symptoms may be difficult for elderly patients with cognitive impairment, and many elderly women have preexisting genitourinary symptoms, such as incontinence. A third of LTCF-patients with ASB are treated with antibiotics, contrary to guideline recommendations. Treatment of ASB has no effect on mortality or hospital admissions for UTI, but contributes to antibiotic resistance, drug toxicity and interaction, and carries an eight-fold increased risk of Clostridioides infection.
The primary objective of this proof-of-concept, pilot study is to identify specific urine biomarkers that can discriminate ASB from UTI in women over the age of 65. Our secondary objective is to evaluate whether urine biomarkers can discriminate upper from lower UTI. Seven different urine biomarkers will be quantified using mass spectrometry and ELISA. Patients will be recruited in long term care facilities, general practices and regional hospitals.
Study objective
We postulate that a specific urine biomarker or biomarker panel can discriminate ASB from UTI
Study design
There will only be one time point for patients with upper/lower UTI and patients without UTI. Patients with ASB will be asked to produce a second urine sample four weeks after the first culture, as ASB cannot be determined with one urine culture.
Intervention
No intervention, only collection of a urine sample
Inclusion criteria
- Female, aged > 65
- Pyuria
- New onset of ≥ 2 symptoms: frequency, urgency, dysuria, suprapubic tenderness
Exclusion criteria
- Inability to express symptoms
- Immunosuppressive therapy
- Previous urological surgery
- Active glomerulonephritis
- Urologic malignancy
- Bladder irrigations
- Pretreatment with antibiotics in previous 48 hours
- UTI in preceding month
- Present urolithiasis
- Presence of urinary catheter
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
Register | ID |
---|---|
NTR-new | NL9477 |
Other | METC-LDD : N21.020 |