Diagnostic Value of Rapid Fluorescence Staining for the Etiological Analysis of Urinary Tract Infections

Assessment of Rapid Dual-Fluorescence Staining of Urine for Diagnosing Urinary Tract Infections

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2600122997

Enrollment

Unknown

Registered

2026-04-20

Start date

2026-05-06

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Tract Infection, UTI

Interventions

Gold Standard:Urine Culture Results

Index test:Urine Culture Results? Microscopic Analysis of Fluorescence-Stained Urine

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-75, any sex (females must be non-menstruating). 2. Infection Group: Urine samples from symptomatic patients (frequency, urgency, dysuria, suprapubic pain) with a positive urinalysis finding for at least one of the following: bacteria, nitrite, WBCs, leukocyte esterase, or fungi. 3. Healthy Control Group: No history or symptoms of UTI, and with completely negative urinalysis results. 4. Specimens must be clearly labeled and have traceable information.

Exclusion criteria

Exclusion criteria: 1. Inability to obtain urine culture results. 2. Urine culture indicating contamination; 3. Incomplete or missing case information. 4. Use of antibiotics within the past 4 weeks. 5. Patients with malignancies, severe concurrent infections, neurological diseases, psychiatric disorders, or cognitive impairment.

Design outcomes

Primary

Measure	Time frame
Sensitivity;Accuracy;Specificity;	—

Countries

China

Contacts

Public ContactHuanhuan Qin

Huashan Hospital, Fudan University

B1052@huashan.org.cn+86 21 66894755

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026