NCT06918769 The Application of a Novel Urinalysis System (UF-5000) for Reducing Unnecessary Antibiotic Use in Clinical Suspected UTI Patients
| NCT ID | NCT06918769 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Hong Kong |
| Condition | Urinary Tract Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-11-06 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2023-11-06 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Urinary tract infection (UTI) is one of the most common diseases in population while antibiotic resistant in UTI has become a critical problem in Hong Kong, that a large proportion of the bacteria in UTI resistant to commonly used anti-UTI antibiotic treatment. This is largely due to the empirical treatment (i.e. no bacteria information is available at the time of treatment) and overtreatment of antibiotics in the past decades. Some patients who did not actually have UTI were prescribed with antibiotics because they have symptoms similar to UTI. In order to avoid unnecessary use of antibiotics and therefore reduce the antibiotic resistance rates of UTI, we propose to apply a new urine sediment analyzer (UF-5000) in clinical practice for UTI which could provide quick label for potential bacteria in urine, and give more information on the possible species of the bacteria. UF-5000 is a urine sediment analyzer manufactured by Sysmex Ltd. (Japan), it is widely used in central laboratories of hospitals and private laboratories, but not commonly seen in out-patient clinic setting. UF-5000 is capable of counting the amount of bacteria present in the given urine sample and provide Gram staining\*, with results available within 5 minutes. While routine urine culture would take around 3 days. A study done by The University of Hong Kong in 2019 has shown that UF-5000 has higher accuracy than conventional dipstick, with reliable Gram staining result. It has a negative-prediction value of 96%, which means it could accurately identify the cases who had no UTI but only similar symptoms. Those cases were mostly inflammatory diseases that did not require antibiotics. This study aims to evaluate whether bacteria information provided by UF-5000 would be able to guide a precision use of antibiotic treatment and avoid unnecessary antibiotic use.
Eligibility Criteria
Inclusion Criteria: 1. Adult patients who are suspected to have LUTs in outpatient clinic. 2. Willing to consent to participate the trial. 3. Be able to understand the nature of the study. Exclusion Criteria: 1. Any suspected or known sexual transmitted diseases. (Such as gonorrhea, etc.) 2. Use of any systematic antibiotics or antiviral treatment within two weeks 3. With evidence of systematic infection including high fever, significantly increase of blood white blood cell count, etc. 4. Known or suspected allergic history/adverse drug reactions to any antibiotics 5. With previous history of multidrug resistant (MDR) bacterial infection. 6. Any medical history that indicates the need of immediate antibiotics treatment, such as chronic conditions and/or taking immunosuppressants.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06918769 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Urinary Tract Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06918769 currently recruiting?
Yes, NCT06918769 is actively recruiting participants. Contact the research team at stac@hku.hk for enrollment information.
Where is the NCT06918769 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT06918769 clinical trial?
NCT06918769 is sponsored by The University of Hong Kong. The trial plans to enroll 200 participants.