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A new tNGS technology applied in drug resistant tuberculosis diagnosis of prospective controlled study

A new tNGS technology applied in drug resistant tuberculosis diagnosis of prospective controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300078691
Enrollment
Unknown
Registered
2023-12-15
Start date
2023-12-15
Completion date
Unknown
Last updated
2023-12-19

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

Conditions

Tuberculosis

Interventions

Gold Standard:Cultivation of mycobacterium tuberculosis
Index test:Sputum or bronchoalveolar lavage fluid samples were collected from adult suspected PTB patients, and the performance of smear, culture, XpertMTB/RIF, mNGS, tNGS and Nanopore in the detectio

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) tuberculosis related clinical symptoms (such as cough, fever, night sweats) and imaging changes (for example, granuloma and cavity), gamma interferon release test positive as suspected PTB cases into the group. 2) at least 18 years old. 3) past, who was not involved in other clinical trials.

Exclusion criteria

Exclusion criteria: 1) severe disseminated tuberculosis with an expected survival of no more than 3 months as judged by the competent physician 2) during pregnancy or lactation women 3) the people with TB diagnosis (any) meet the following: a There was no evidence of tuberculosis infection b) clearly other pathogen infection c. Non-anti-tuberculosis treatment is effective

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;

Secondary

MeasureTime frame
Ability to detect drug-resistance mutations in first - and second-line TB drugs;Accuracy ;Positive predicative value;

Countries

China

Contacts

Public ContactHe Jianqing

West China Hospital, Sichuan University

jianqing_he@scu.edu.cn+86 189 8060 2293

Outcome results

None listed

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