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A Multicenter Prospective Clinical Evaluation Study on Molecular Diagnosis of Tuberculosis Using Tongue Swabs

A Multicenter Prospective Clinical Evaluation Study on Molecular Diagnosis of Tuberculosis Using Tongue Swabs

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400088076
Enrollment
Unknown
Registered
2024-08-09
Start date
2024-05-26
Completion date
Unknown
Last updated
2024-08-12

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

Conditions

Tuberculosis

Interventions

Sponsors

Beijing Chest Hospital Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for suspected pulmonary tuberculosis 1) Have suspected symptoms of TB, including fever, chest pain, chest tightness, cough, phlegm or blood coughing; 2) Imaging findings indicate lung lesions, with specific characteristics conforming to any of the following: (a) Voids (b) bronchiectasis and nodules (c) Clumps or scattered patchy ground glass shadows (d) Pulmonary plaque and bronchial spread (e) Other special types: such as "hot bath" lungs, solitary nodules, etc.; 3) have received anti-TB drugs for less than two weeks (recalculation from suspected recurrence); 4) The sample volume meets the requirements of 3.4.2.1; 5) Over 18 years old; 6) Sign informed consent.

Exclusion criteria

Exclusion criteria: Exclusion criteria 1) Pathogen specimens with sufficient sample size are not obtained as expected; 2) extrapulmonary tuberculosis; 3) The patient is under 18 years old or pregnant women; 4) No informed consent can be obtained.

Design outcomes

Primary

MeasureTime frame
Estimate sensitivity and specificity for tongue swab analysis for suspected pulmonary tuberculosis in adults, with 95% confidence intervals;

Secondary

MeasureTime frame
Difference of oral flora between tongue swab positive and tongue swab negative patients with tuberculosis;The success rate of tongue swab detection under different bacterial loads;

Countries

China

Contacts

Public ContactPang Yu

Beijing Chest Hospital Affiliated to Capital Medical University

pangyupound@163.com+86 138 1009 8209

Outcome results

None listed

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