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Multi-gene analysis of identification, differentiation and antibiotic resistance of Mycobacterium tuberculosis

Multi-gene analysis of identification, differentiation and antibiotic resistance of Mycobacterium tuberculosis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000037564
Enrollment
Unknown
Registered
2020-08-28
Start date
2020-01-01
Completion date
Unknown
Last updated
2020-10-26

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

Conditions

Tuberculosis

Interventions

Gold Standard:MTB conventional culture from sputum
Index test:Multi-gene&#32
&#32
and&#32
acid-fast&#32

Sponsors

Huadong Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: From Jan 2020 to Dec 2021, patients with TB or suspected TB from Huadong Hospital and Pulmonary Hospital, as well as patients infected with NTM, are of any age or gender. The diagnosis of pulmonary tuberculosis adopts the diagnostic criteria and treatment principles in the WS288-2017 and the fourth edition of the WHO TB treatment guidelines. Cough, spit >=2w, or hemoptysis is a suspicious symptom of pulmonary TB. Imaging examinations must have typical imaging findings. The pathogenic diagnosis must be based on the detection of related pathogens or specific nucleic acids from sputum samples. MTB was cultivated in the sample. The diagnostic criteria for extrapulmonary TB is positive MTB culture; pathological biopsy confirmed positive for caseous granuloma or acid-fast bacilli; chest X-ray showed miliary shadows of both lungs; anti-TB treatment is effective. NTM infection criteria: clinically exclude TB, or detect NTM in clinical samples.

Exclusion criteria

Exclusion criteria: The patient had no clinical symptoms of tuberculosis and no signs of tuberculosis in imaging. The laboratory test results showed that no colonies were found after the sample was cultured for 8 weeks. There were no mycobacteria in the 3 sputum smear microscopy. The T-spot experiment and GeneXpert-MTB-RIF also showed Negative.

Design outcomes

Primary

MeasureTime frame
MTB;

Countries

China

Contacts

Public ContactHu Zhao

Huadong Hospital

hubertzhao@163.com+86 13701618011

Outcome results

None listed

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