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Identification and rapid detection of drug resistance of nontuberculous mycobacteria

Identification and rapid detection of drug resistance of nontuberculous mycobacteria based on massarray time of flight mass spectrometry platform

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100050109
Enrollment
Unknown
Registered
2021-08-16
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-04-25

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

Conditions

Mycobacterial lung disease

Interventions

Gold Standard:16S rDNA sequencing
Index test:Time&#32
of&#32
flight&#32
MassArray&#32
technology

Sponsors

Shanghai Pulmonary Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Mycobacterium culture in sputum or other specimens is positive, but its growth or colony morphology is suspected to be NTM; 2. Acid-fast staining of sputum or other specimens or positive for mycobacterial culture, negative for MTB molecular biology test and positive for NTM molecular biology test; 3. Sputum or other specimens are positive for mycobacterial culture, positive for p-nitrobenzoic acid culture and/or negative for MPB64 antigen test, but do not meet the diagnostic criteria; 4. Have imaging manifestations of NTM disease, but lack the basis for bacteriological diagnosis of NTM; 5. Has the pathological manifestations of mycobacterial infection, but lacks the basis for the bacteriological diagnosis of NTM; 6. Long-term non-healing of the wound after iatrogenic or non-iatrogenic tissue injury, positive acid-fast staining, negative molecular biology test for Mycobacterium tuberculosis, and lack of bacteriological basis for NTM.

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

MeasureTime frame
type of bacteria;

Countries

China

Contacts

Public ContactGu Jin

Shanghai Pulmonary Hospital

gujin51250@163.com+86 13621648976

Outcome results

None listed

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