Urinary Tract InfectionsNCT06918769
The Application of a Novel Urinalysis System (UF-5000) for Reducing Unnecessary Antibiotic Use in Clinical Suspected UTI Patients
A study testing Sysmex UF-5000 system and Empirical antibiotics in people with Urinary Tract Infections and Urinary Tract Infection Lower Acute, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Urinary tract infection (UTI) is one of the most common diseases in the population, while antibiotic resistance in UTI has become a critical problem in Hong Kong, with a large proportion of bacteria causing UTI resistant to commonly used anti-UTI antibiotic treatments. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Urinary Tract Infections, Urinary Tract Infection Lower Acute
- What is being tested?
- Sysmex UF-5000 system and Empirical antibiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteHong Kong
- Study dates
- 6 Nov 2023to 28 Feb 2026
- Phase
- Interventional
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients who are suspected to have LUTs in outpatient clinic.
- Willing to consent to participate the trial.
- Be able to understand the nature of the study.
Who cannot join
- Any suspected or known sexual transmitted diseases. (Such as gonorrhea, etc.)
- Use of any systematic antibiotics or antiviral treatment within two weeks
- With evidence of systematic infection including high fever, significantly increase of blood white blood cell count, etc.
- Known or suspected allergic history/adverse drug reactions to any antibiotics
- With previous history of multidrug resistant (MDR) bacterial infection.
- Any medical history that indicates the need of immediate antibiotics treatment, such as chronic conditions and/or taking immunosuppressants.
Trial locations and contacts
1 site in 1 country.
About this study
Urinary tract infection (UTI) is one of the most common diseases in the population, while antibiotic resistance in UTI has become a critical problem in Hong Kong, with a large proportion of bacteria causing UTI resistant to commonly used anti-UTI antibiotic treatments. This resistance is largely due to empirical treatment (i.e. no bacterial information is available at the time of treatment) and antibiotic overtreatment over the past decades. Some patients without UTI were prescribed antibiotics because of symptoms similar to UTI.
To avoid unnecessary antibiotic use and therefore reduce antibiotic resistance rates in UTI, the investigators propose to apply a new urine sediment analyzer (UF-5000) in clinical practice for UTI. The analyzer could provide rapid identification of potential bacteria in urine and more information on possible bacterial species. UF-5000 is a urine sediment analyzer manufactured by Sysmex Ltd. (Japan). The analyzer is widely used in hospital central laboratories and private laboratories but is not commonly seen in outpatient clinic settings. UF-5000 is capable of counting bacteria present in a urine sample and providing Gram staining results within 5 minutes, while routine urine culture takes around 3 days.
Read more
A study conducted by The University of Hong Kong in 2019 showed that UF-5000 has higher accuracy than conventional dipstick testing, with reliable Gram staining results. The analyzer has a negative predictive value of 96%, indicating a high likelihood that a negative result corresponds to the absence of UTI. Cases with symptoms similar to UTI were mostly inflammatory diseases without a need for antibiotics.
This study aims to evaluate whether bacterial information provided by UF-5000 can guide precise antibiotic treatment and avoid unnecessary antibiotic use.
- Being tested
- Sysmex UF-5000 system, Empirical antibiotics
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sysmex UF-5000 systemDiagnostic test
Provide real time bacterial count in urine samples and Gram-staining results. High bacterial count suggests likelihood of active UTI and indicated for antibiotics treatment; while low bacterial count suggests UTI not likely.
Empirical antibioticsDrug
Empirical antibiotics, including amoxicillin/clavulanate (Augmentin), cefuroxime, ciprofloxacin, levofloxacin, and nitrofurantoin, per local guidelines and/or the investigator's discretion for urinary tract infection.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | Empirical antibiotics, including amoxicillin/clavulanate (Augmentin), cefuroxime, ciprofloxacin, levofloxacin, and nitrofurantoin, without bacterial information. Receives: Drug: Empirical antibiotics |
| Experimental Arm | Experimental | Antibiotics prescription with reference from study device. High bacterial count suggests likelihood of active UTI and indicated for antibiotics treatment; while low bacterial count suggests UTI not likely and antibiotics treatment will be delayed until urinary culture result confirms ongoing UTI. Receives: Diagnostic Test: Sysmex UF-5000 system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects assigned with "Delay antibiotics treatment" in the intervention group that has confirmed no clinical indication for antibiotics treatment
The rate of unnecessary antibiotics use avoided in the intervention group. Defined as proportion of subjects assigned with "Delay antibiotics treatment" as indicated by low real-time bacterial count in urine that had negative or clinically insignificant urine culture result in one week.
Measured: 1 week
Secondary outcomes (3)
Number of subjects achieved urinary sterility after antibiotics treatment in confirmatory urine test
Defined as negative white blood cell in urine dipstick and no growth in urine culture. Only applies to subjects that have finished a course of antibiotics treatment under study setting.
Measured: 1 week
Number of participants that persist to have baseline lower tract urinary symptoms as assessed in CTCAE 4.0
The symptoms would be assessed through phone follow-up.
Measured: 1 week
Number of participants with antibiotics treatment-related adverse events as assessed by CTCAE v4.0
The symptoms would be assessed through phone follow-up.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start6 Nov 2023
- Primary completion31 Dec 2025
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Sysmex Asia Pacific
- Responsible party
- Principal investigator, Yung NA, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918769
- Sponsor's protocol ID
- HKURO202201
- Status last verified
- Oct 2026
- First submitted
- 7 May 2024
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of a Novel Urinalysis System (UF-5000) for Reducing Unnecessary Antibiotic Use in Clinical Suspected UTI Patients
- ClinicalTrials.gov ID
- NCT06918769
- Acronym / sponsor ID
- HKURO202201
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Sysmex Asia Pacific
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 9 Apr 2025 (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.
Urinary tract infection (UTI) is one of the most common diseases in the population, while antibiotic resistance in UTI has become a critical problem in Hong Kong, with a large proportion of bacteria causing UTI resistant to commonly used anti-UTI antibiotic treatments. This resistance is largely due to empirical treatment (i.e. no bacterial information is available at the time of treatment) and antibiotic overtreatment over the past decades. Some patients without UTI were prescribed antibiotics because of symptoms similar to UTI.
To avoid unnecessary antibiotic use and therefore reduce antibiotic resistance rates in UTI, the investigators propose to apply a new urine sediment analyzer (UF-5000) in clinical practice for UTI. The analyzer could provide rapid identification of potential bacteria in urine and more information on possible bacterial species. UF-5000 is a urine sediment analyzer manufactured by Sysmex Ltd. (Japan). The analyzer is widely used in hospital central laboratories and private laboratories but is not commonly seen in outpatient clinic settings. UF-5000 is capable of counting bacteria present in a urine sample and providing Gram staining results within 5 minutes, while routine urine culture takes around 3 days.
A study conducted by The University of Hong Kong in 2019 showed that UF-5000 has higher accuracy than conventional dipstick testing, with reliable Gram staining results. The analyzer has a negative predictive value of 96%, indicating a high likelihood that a negative result corresponds to the absence of UTI. Cases with symptoms similar to UTI were mostly inflammatory diseases without a need for antibiotics.
This study aims to evaluate whether bacterial information provided by UF-5000 can guide precise antibiotic treatment and avoid unnecessary antibiotic use.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Active comparator | Drug: Empirical antibioticsEmpirical antibiotics, including amoxicillin/clavulanate (Augmentin), cefuroxime, ciprofloxacin, levofloxacin, and nitrofurantoin, without bacterial information. |
| Experimental Arm | Experimental | Diagnostic Test: Sysmex UF-5000 systemAntibiotics prescription with reference from study device. High bacterial count suggests likelihood of active UTI and indicated for antibiotics treatment; while low bacterial count suggests UTI not likely and antibiotics treatment will be delayed until urinary culture result confirms ongoing UTI. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients who are suspected to have LUTs in outpatient clinic.
- Willing to consent to participate the trial.
- Be able to understand the nature of the study.
Key exclusion criteria (6 listed)
- Any suspected or known sexual transmitted diseases. (Such as gonorrhea, etc.)
- Use of any systematic antibiotics or antiviral treatment within two weeks
- With evidence of systematic infection including high fever, significantly increase of blood white blood cell count, etc.
- Known or suspected allergic history/adverse drug reactions to any antibiotics
- With previous history of multidrug resistant (MDR) bacterial infection.
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 |
|---|---|---|
| Sysmex UF-5000 systemProvide real time bacterial count in urine samples and Gram-staining results. High bacterial count suggests likelihood of active UTI and indicated for antibiotics treatment; while low bacterial count suggests UTI not likely. | Diagnostic test | Experimental Arm |
| Empirical antibioticsEmpirical antibiotics, including amoxicillin/clavulanate (Augmentin), cefuroxime, ciprofloxacin, levofloxacin, and nitrofurantoin, per local guidelines and/or the investigator's discretion for urinary tract infection. | Drug | Control Arm |
Primary outcome
Proportion of subjects assigned with "Delay antibiotics treatment" in the intervention group that has confirmed no clinical indication for antibiotics treatment
Time frame: 1 week
The rate of unnecessary antibiotics use avoided in the intervention group. Defined as proportion of subjects assigned with "Delay antibiotics treatment" as indicated by low real-time bacterial count in urine that had negative or clinically insignificant urine culture result in one week.
3 secondary outcomes
Number of subjects achieved urinary sterility after antibiotics treatment in confirmatory urine test
Time frame: 1 week
Number of participants that persist to have baseline lower tract urinary symptoms as assessed in CTCAE 4.0
Time frame: 1 week
Number of participants with antibiotics treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sysmex UF-5000 system and Empirical antibiotics in people with Urinary Tract Infections and Urinary Tract Infection Lower Acute, run by The University of Hong Kong at 1 site in Hong Kong.
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 6 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: finished, as of the sponsor's last update on 3 Nov 2026. 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 Hong Kong. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects assigned with "Delay antibiotics treatment" in the intervention group that has confirmed no clinical indication for antibiotics treatment (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2026.