Urinary Tract Infection (Diagnosis)UTI-GOLDNCT06610721
'Improving Urinary Tract Infection Diagnosis in Older Patients: Validation of a Biomarker Panel (UTI-GOLD)'
An observational study of Urinary Tract Infection (Diagnosis), run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
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 What is the optimal cut-off for each individual biomarker NGAL,IL-6,AZU,TIMP2 and CXCL9 and associated, sensitivity, specificity, negative and positive… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Urinary Tract Infection (Diagnosis)
- What is being tested?
- Urine Biomarkers
- How many people
- 264 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Aug 2024to 15 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: 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.
Who may be able to join
- Age 65 years or older
- Clinically suspected UTI by treating physician
- Sufficient understanding of the Dutch language
Who cannot join
- Inability to obtain urine
- Inability to provide written consent
- The presence of an indwelling catheter
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Leiden university medical center (LUMC)
Leiden, South Holland, 2333 ZA
Nora El Moussaoui, 0031634531571, n.el_moussaoui@lumc.nl
About this study
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
Read more
- What is the optimal cut-off for each individual biomarker NGAL,IL-6,AZU,TIMP2 and CXCL9 and associated, sensitivity, specificity, negative and positive predictive value.
- sensitivity, specificity, negative and positive predictive value of a urine leukocyte count cut-off of 200 cells/microL (validation)
- What is the optimal combination of biomarkers for UTI diagnosis in older patients
- As a secondary objective this study aims to evaluate the association between the levels of individual biomarker levels and 1) duration of symptoms 2) complications, 3) recurrence of UTI within 2 months, and length of hospital stay. Next to this, the performance of the astrego PA100 will be validated in diagnosing bacteriuria.
Participants will:
- be asked to provide a urine sample once at the beginning of the study
- be asked to answer some questions about their symptoms and overall health at the beginning of the study and after 8 weeks
- have their vital parameters (temperature and blood pressure) measured once at the beginning of the study
- Conditions
- Urinary Tract Infection (Diagnosis)
- Being tested
- Urine Biomarkers
- Keywords
- Urinary tract infection, Biomarkers
- Medical subject headings
- Urinary Tract Infections, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine BiomarkersDiagnostic test
At baseline midstream urine will be collected in a sterile urine container.
| Study group | Role | What they receive |
|---|---|---|
| Elderly patients with a suspected urinary tract infection | Not described Receives: Diagnostic Test: Urine Biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of individual urine biomarkers
Sensitivity and specificity in percentages for the different biomarkers include; NGAL, IL-6, AZU, TIMP2 and CXCL9.
Measured: 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.
Measured: At Baseline
Diagnostic accuracy of individual urine biomarkers
Likelihood ratios for the different biomarkers include; NGAL, IL-6, AZU, TIMP2 and CXCL9.
Measured: 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.
Measured: At Baseline
Diagnostic accuracy of urine biomarker panel
Sensitivity and specificity in percentages for the optimal combination of biomarkers
Measured: At Baseline
Diagnostic accuracy of urine biomarker panel
positive and negative predictive values in percentages for the optimal combination of biomarkers.
Measured: At Baseline
Diagnostic accuracy of urine biomarker panel
The likelihood ratios for the optimal combination of biomarkers.
Measured: At Baseline
Diagnostic accuracy of urine biomarker panel
The area under the receiver operating characteristic curve (AUC) for the optimal combination of biomarkers.
Measured: At Baseline
Diagnostic accuracy of leukocytes in urine
Sensitivity and specificity in percentages for the cut-off of 200 leukocytes/microL in urine.
Measured: 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
Measured: At Baseline
Secondary outcomes (5)
Duration of symptoms
Measured: 1 week after inclusion, if not yet resolved again at 8 weeks
Length of hospital stay
Measured: 1 week after inclusion, if not yet resolved again at 8 weeks
Complications
Measured: 1 week after inclusion, if not yet resolved again at 8 weeks
Recurrence of UTI <2 months
Measured: 8 weeks after inclusion
Diagnostic performance of PA100 in detecting bacteruria
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start20 Aug 2024
- Primary completion20 Aug 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract Infection (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nora El Moussaoui, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06610721
- Sponsor's protocol ID
- nWMODIV2_2024025
- Acronym
- UTI-GOLD
- Status last verified
- Sep 2024
- First submitted
- 19 Sep 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data will be shared in a registry. after completion of the study. The data sharing plan will be developed
Publications
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.
PubMed 40533212
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 'Improving Urinary Tract Infection Diagnosis in Older Patients: Validation of a Biomarker Panel (UTI-GOLD)'
- ClinicalTrials.gov ID
- NCT06610721
- Acronym / sponsor ID
- UTI-GOLD / nWMODIV2_2024025
- Conditions
- Urinary Tract Infection (Diagnosis)
- Keywords
- Urinary tract infection, Biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 20 Aug 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- What is the optimal cut-off for each individual biomarker NGAL,IL-6,AZU,TIMP2 and CXCL9 and associated, sensitivity, specificity, negative and positive predictive value.
- sensitivity, specificity, negative and positive predictive value of a urine leukocyte count cut-off of 200 cells/microL (validation)
- What is the optimal combination of biomarkers for UTI diagnosis in older patients
- As a secondary objective this study aims to evaluate the association between the levels of individual biomarker levels and 1) duration of symptoms 2) complications, 3) recurrence of UTI within 2 months, and length of hospital stay. Next to this, the performance of the astrego PA100 will be validated in diagnosing bacteriuria.
Participants will:
- be asked to provide a urine sample once at the beginning of the study
- be asked to answer some questions about their symptoms and overall health at the beginning of the study and after 8 weeks
- have their vital parameters (temperature and blood pressure) measured once at the beginning of the study
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly patients with a suspected urinary tract infection | – | Diagnostic Test: Urine Biomarkers |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Age 65 years or older
- Clinically suspected UTI by treating physician
- Sufficient understanding of the Dutch language
Key exclusion criteria (3 listed)
- Inability to obtain urine
- Inability to provide written consent
- The presence of an indwelling catheter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urine BiomarkersAt baseline midstream urine will be collected in a sterile urine container. | Diagnostic test | Elderly patients with a suspected urinary tract infection |
Primary outcome
Diagnostic accuracy of individual urine biomarkers
Time frame: At Baseline
Sensitivity and specificity in percentages for the different biomarkers include; NGAL, IL-6, AZU, TIMP2 and CXCL9.
Diagnostic accuracy of individual urine biomarkers
Time frame: At Baseline
Positive and negative predictive value in percentages for the different biomarkers include; NGAL, IL-6, AZU, TIMP2 and CXCL9.
Diagnostic accuracy of individual urine biomarkers
Time frame: At Baseline
Likelihood ratios for the different biomarkers include; NGAL, IL-6, AZU, TIMP2 and CXCL9.
Diagnostic accuracy of individual urine biomarkers
Time frame: At Baseline
Area under the receiver operating characteristic curve (AUC) for the different biomarkers include; NGAL, IL-6, AZU, TIMP2 and CXCL9.
Diagnostic accuracy of urine biomarker panel
Time frame: At Baseline
Sensitivity and specificity in percentages for the optimal combination of biomarkers
Diagnostic accuracy of urine biomarker panel
Time frame: At Baseline
positive and negative predictive values in percentages for the optimal combination of biomarkers.
Diagnostic accuracy of urine biomarker panel
Time frame: At Baseline
The likelihood ratios for the optimal combination of biomarkers.
Diagnostic accuracy of urine biomarker panel
Time frame: At Baseline
The area under the receiver operating characteristic curve (AUC) for the optimal combination of biomarkers.
Diagnostic accuracy of leukocytes in urine
Time frame: At Baseline
Sensitivity and specificity in percentages for the cut-off of 200 leukocytes/microL in urine.
Diagnostic accuracy of leukocytes in urine
Time frame: At Baseline
Negative and positive predictive value in percentages for the cut-off of 200 leukocytes/microL in urine
5 secondary outcomes
Duration of symptoms
Time frame: 1 week after inclusion, if not yet resolved again at 8 weeks
Length of hospital stay
Time frame: 1 week after inclusion, if not yet resolved again at 8 weeks
Complications
Time frame: 1 week after inclusion, if not yet resolved again at 8 weeks
Recurrence of UTI <2 months
Time frame: 8 weeks after inclusion
Diagnostic performance of PA100 in detecting bacteruria
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Derived from this study: PubMed 40533212El 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.
- Individual participant dataSharing planned: Yes. data will be shared in a registry. after completion of the study. The data sharing plan will be developed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infection (Diagnosis), run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nora El Moussaoui (0031-0634531571, n.el_moussaoui@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of individual urine biomarkers (time frame: At Baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06610721, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.