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Identification and drug resistance prediction of non-tuberculosis mycobacterium based on nanopore targeted sequencing

Identification and drug resistance prediction of non-tuberculosis mycobacterium based on nanopore targeted sequencing

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400080660
Enrollment
Unknown
Registered
2024-02-04
Start date
2024-02-05
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Non-tuberculous mycobacterium lung disease

Interventions

Gold Standard: Microbroth dilution
whole genome sequencing
Index test:Nanopore high-throughput targeted sequencing

Sponsors

Wenzhou Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age =18 years old, gender unlimited. 2. Meet the diagnostic criteria for suspected NTM lung disease, refer to China's "Guidelines for the Diagnosis and Treatment of Nontuberculous Mycobacteriosis 2020 Edition" : ? The sputum or bronchoalveolar lavage fluid is positive for acid-fast bacilli, but the clinical manifestations are inconsistent with tuberculosis; ? Abnormal mycobacteria were found in sputum or lavage fluid samples by microscope examination; ? The sputum or lavage fluid samples were positive for mycobacterium culture, but the colony morphology and growth were different from MTB. ? Sputum or lavage fluid samples were positive for acid-fast bacilli but negative for MTB molecular biology; ? Patients who received regular anti-tuberculosis therapy failed and repeated bacterial expulsion, and the lung lesions were mainly bronchiectasis, multiple nodules and parenchyma cavities; Cough cough sputum for more than 2 weeks, hemoptysis, wasting, fatigue, or night sweating have clinical symptoms of tuberculosis, but MTB molecular biological test and tuberculin skin test (TST) or Interferon-Gamma Release Assays (IGRAs) or recombinant tuberculosis fusion protein (ESAT6-CFP10, EC) are negative, imaging suspected NTM lung disease; ? Patients with pulmonary disease who have immune deficiency except tuberculosis. 3. The bronchoscopy physician assesses the patient's condition to tolerate alveolar lavage and obtain sufficient alveolar lavage fluid. 4. Subjects voluntarily participate in this study and sign informed consent; If the subject is unable to participate in the informed consent process, his/her legal representative must participate in the informed consent process and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Not enough qualified bronchoalveolar lavage fluid specimens were obtained as expected. 2. Patients undergoing anti-mycobacterium therapy.

Design outcomes

Primary

MeasureTime frame
Species identification;Antimicrobial susceptibility;Accuracy;Sensitivity;Specificity;

Countries

China

Contacts

Public ContactHe Guiqing

Wenzhou Central Hospital

hegq123@126.com+86 137 7775 0017

Outcome results

None listed

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