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Feasibility study on detection of gonococcal/Chlamydia trachomatis/ureaplasma Urealyticum infection in urine and reproductive tract samples by fluorescence quantitative PCR

Feasibility study on detection of gonococcal/Chlamydia trachomatis/ureaplasma Urealyticum infection in urine and reproductive tract samples by fluorescence quantitative PCR

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500102678
Enrollment
Unknown
Registered
2025-05-19
Start date
2024-05-08
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Gonococcal/Chlamydia trachomatis/ureaplasma urealyticum infection

Interventions

Gold Standard:Second generation sequencing (NGS), NG, CT, UU nucleic acid detection reagents
Index test:Method for detecting NG, CT, and UU nucleic acids using fluorescence quantitative PCR technology

Sponsors

Beijing Ditan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years old; 2. Sexual life history; 3. Suspected NG, CT, UU infection (including but not limited to the occurrence of related symptoms, high-risk sexual behavior, health examination, etc.), and voluntarily accept relevant tests; 4. "Disease group" : subjects infected with one or more NG, CT, UU; 5. "Control group" : subjects did not have NG, CT, UU infection; 6. Volunteer to participate in this study and sign the informed consent after communication.

Exclusion criteria

Exclusion criteria: 1. Clinical manifestations were limited to the non-urogenital system such as eyes, pharynx, anus and rectum; 2. Received local or systemic anti-infection treatment in the past 21 days; 3. Received urethral or reproductive tract irrigation in the last 24 hours; 4. Known pregnant or lactating women; 5. Unable to complete sample collection; 6. Refusal or inability to sign informed consent.

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;

Countries

China

Contacts

Public ContactYajie Wang

Beijing Ditan Hospital, Capital Medical University

wangyajie@ccmu.edu.cn+86 10 84322429

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026