A Prospective Controlled Study on the Tuberculosis Diagnosis using a Novel Live-bacteria Metabolic Labeling Probes

Status

Recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2500098704

Enrollment

Unknown

Registered

2025-03-12

Start date

2024-07-16

Completion date

Unknown

Last updated

2025-03-17

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

Conditions

tuberculosis

Interventions

Gold Standard:GeneXpert, culture and smear of Sputum, BALF, blood, urine,CSF,hydrothorax,seroperitoneum,hydropericardium, purulent secretion

Index test:the novel live-bacteria metabolic labeling probe

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1: 18 years or older 2: Refer to the World Health Organization's Tuberculosis Program Manual for the etiological confirmation of tuberculosis patients, clinical diagnosis of tuberculosis patients, and other patients who do not have tuberculosis 3: No previous treatment for TB or treatment within 7days

Exclusion criteria

Exclusion criteria: 1: Patients with pregnancy or lactation 2: Patients with a history of tuberculosis 3: Patients deemed ineligible for enrollment by the research staff

Design outcomes

Primary

Measure	Time frame
Positive Predictive Value;Negative Predictive Value;Sensitivity;Specificity;Accuracy;	—

Countries

China

Contacts

Public ContactLu Hongzhou

The Third People's Hospital of Shenzhen

luhongzhou@szsy.sustech.edu.cn+86 189 3081 0088

Outcome results

None listed

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