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Clinical evaluation of molecular diagnostic methods for tuberculosis based on tongue swab

Clinical evaluation of molecular diagnostic methods for tuberculosis based on tongue swab

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500115132
Enrollment
Unknown
Registered
2025-12-23
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Tuberculosis

Interventions

Gold Standard:1. Microbiological standard: positive sputum culture
2. Molecular biological standard: sputum Xpert MTB/RIF was positive
3. Clinical diagnostic criteria: The expert group comprehensively judged active pulmonary tuberculosis according to imaging and treatment response.
Index test:Fluorescence quantitative PCR detection based on tongue swab

Sponsors

Huzhou Center Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Suspected symptoms of tuberculosis, including fever, chest pain, chest tightness, cough, expectoration or hemoptysis; 2. Imaging shows that there are lung lesions, and the specific characteristics should meet any of the following: cavity, bronchiectasis, nodular mass or scattered patchy ground glass shadow, patchy shadow in lung and bronchial disseminated focus, other special types, such as "hot water bath" lung, solitary nodule, etc. 3. Have been treated with anti-tuberculosis drugs for less than two weeks (recurrence is recalculated from suspected recurrence); 4.18 years old or above.

Exclusion criteria

Exclusion criteria: 1. Did not get enough samples of pathogens as expected; 2. Extrapulmonary tuberculosis; 3. Patients under the age of 18 or pregnant women and those who are underweight.

Design outcomes

Primary

MeasureTime frame
Tongue swab of mycobacterium tuberculosis DNA;

Secondary

MeasureTime frame
Sensitivity of sputum for MTB detection;Adverse Event Rate;Oral microbiota profile;

Countries

China

Contacts

Public ContactSong Qun

Huzhou Center Hospital

chenhuasongqun1976@163.com+86 572 2655579

Outcome results

None listed

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