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The goal of this study is to improve the diagnosis of urinary tract infections (UTI) in older people (≥65 years). The main research questions are:
Research questions
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elderly patients with a suspected urinary tract infection |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urine Biomarkers | Diagnostic Test | At baseline midstream urine will be collected in a sterile urine container. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of individual urine biomarkers | Sensitivity and specificity in percentages for the different biomarkers include; NGAL, IL-6, AZU, TIMP2 and CXCL9. | At Baseline |
| Diagnostic accuracy of individual urine biomarkers | Positive and negative predictive value in percentages for the different biomarkers include; NGAL, IL-6, AZU, TIMP2 and CXCL9. | At Baseline |
| Diagnostic accuracy of individual urine biomarkers | Likelihood ratios for the different biomarkers include; NGAL, IL-6, AZU, TIMP2 and CXCL9. | At Baseline |
| Diagnostic accuracy of individual urine biomarkers | Area under the receiver operating characteristic curve (AUC) for the different biomarkers include; NGAL, IL-6, AZU, TIMP2 and CXCL9. | At Baseline |
| Diagnostic accuracy of urine biomarker panel | Sensitivity and specificity in percentages for the optimal combination of biomarkers | At Baseline |
| Diagnostic accuracy of urine biomarker panel | positive and negative predictive values in percentages for the optimal combination of biomarkers. | At Baseline |
| Diagnostic accuracy of urine biomarker panel | The likelihood ratios for the optimal combination of biomarkers. | At Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of symptoms | 1 week after inclusion, if not yet resolved again at 8 weeks | |
| Length of hospital stay | 1 week after inclusion, if not yet resolved again at 8 weeks | |
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Inclusion criteria:
Exclusion criteria:
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Patients will be recruited in the hospital setting, long term care and general practice. Patients will be recruited through an existing network of hospitals, primary care offices and long stay facilities in the Leiden and the Hague region (the Netherlands). Additionally, there is a collaboration with university college hospital in London (the UK).
Patients with suspected UTI in these centers will be identified by their attending healthcare provider. The attending healthcare provider will notify the study team, who will proceed the inclusion process.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nora El Moussaoui | Contact | 0031-0634531571 | n.el_moussaoui@lumc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden university medical center (LUMC) | Recruiting | Leiden | South Holland | 2333 ZA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40533212 | Derived | El Moussaoui N, van Andel E, van der Beek MT, Vlot JA, Bilsen MP, van Nieuwkoop C, Lauw FN, Delfos NM, Stalenhoef JE, Sijbom M, Akintola AA, Achterberg WP, Goeman JJ, Leyten EMS, van Uhm JIM, Corstjens PLAM, Mooijaart SP, Conroy SP, Cobbaert CM, Visser LG, Lambregts MMC. Validation of urinary biomarkers for accurate diagnosis of urinary tract infections in older adults across primary care, hospitals and long-term care facilities in the Netherlands and UK (UTI-GOLD): a multicentre observational study protocol. BMJ Open. 2025 Jun 18;15(6):e103311. doi: 10.1136/bmjopen-2025-103311. |
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data will be shared in a registry. after completion of the study. The data sharing plan will be developed
to be determined
to be determined
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D004194 | Disease |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Urine
| Diagnostic accuracy of urine biomarker panel | The area under the receiver operating characteristic curve (AUC) for the optimal combination of biomarkers. | At Baseline |
| Diagnostic accuracy of leukocytes in urine | Sensitivity and specificity in percentages for the cut-off of 200 leukocytes/microL in urine. | At Baseline |
| Diagnostic accuracy of leukocytes in urine | Negative and positive predictive value in percentages for the cut-off of 200 leukocytes/microL in urine | At Baseline |
| Complications |
| 1 week after inclusion, if not yet resolved again at 8 weeks |
| Recurrence of UTI <2 months | 8 weeks after inclusion |
| Diagnostic performance of PA100 in detecting bacteruria | baseline |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |