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Study on the Enhancement of Etiological Positive Rate in Smear-Negative Pulmonary Tuberculosis Using Multi-Sample Molecular Diagnostic Techniques

Study on the Enhancement of Etiological Positive Rate in Smear-Negative Pulmonary Tuberculosis Using Multi-Sample Molecular Diagnostic Techniques

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600123387
Enrollment
Unknown
Registered
2026-04-26
Start date
2026-04-26
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

Smear-negative pulmonary tuberculosis

Interventions

Gold Standard:Sputum specimens were negative by smear, culture, and molecular testing, but the clinical symptoms were consistent with pulmonary tuberculosis.
Index test:For multiple specimen types including sputum, bronchoalveolar lavage fluid, and pathological tissue, molecular testing was performed as follows: Fluorescence quantitative PCR was used to de

Sponsors

Beijing Chest Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 90 Years

Inclusion criteria

Inclusion criteria: Retrospective cohort: 1. Patients with pulmonary tuberculosis who are unable to produce sputum or have negative results on sputum smear, culture, and molecular tests. Prospective cohort: 1.Patients who agree to participate in this project and sign the informed consent form; 2. Patients with pulmonary tuberculosis who are unable to produce sputum or have negative results on sputum smear and molecular tests.

Exclusion criteria

Exclusion criteria: Retrospective cohort: 1. Patients deemed by the investigator to be unsuitable for participation in this study. Prospective cohort: 1.Patients with smear-positive pulmonary tuberculosis (positive on sputum smear, molecular test, or culture); 2. Patients deemed by the investigator to be unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Multi-sample Molecular Test Results;

Countries

China

Contacts

Public ContactChe Nanying

Beijing Chest Hospital, Capital Medical University

cheny0448@163.com+86 136 5139 4654

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026