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The etiological diagnosis of pleural infection by next generation sequencing: a prospective, multicenter clinical research

The etiological diagnosis of pleural infection by next generation sequencing: a prospective, multicenter clinical research

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400082149
Enrollment
Unknown
Registered
2024-03-21
Start date
2022-06-01
Completion date
Unknown
Last updated
2024-03-25

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

Conditions

Pleural diseases

Interventions

Index test:Macrogene sequencing of pathogenic microorganism

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Selection criteria for patients in the experimental group (meeting 1-3 or 1+4 ) 1) Community onset, imaging confirmed pleural effusion, and pleural effusion samples can be obtained within 4 weeks of onset; 2) Clinical symptoms of infectious pleural effusion: fever = 37.5 ?, with or without chest pain, difficulty breathing; 3) Laboratory examination (= 1 item): Elevated blood count (WBC>10.0) × 109/L or N% = 80%), PCT (>0.5ug/L), elevated CRP (>20mg/L); 4) Chest fluid examination (= 1 item): purulent, white blood cell>1000 × 106. Chest fluid pH<7.2, glucose<2.2mmol/L, G staining positive, culture positive;

Exclusion criteria

Exclusion criteria: 1) The nature of pleural effusion is leakage; 2) Clinical diagnosis of malignant pleural effusion; 3) Patients who cannot tolerate thoracocentesis or fiberoptic bronchoscopy examination; 4) Subjects who do not accept clinical research; 5) Poor compliance, unable to complete treatment and follow-up.

Design outcomes

Primary

MeasureTime frame
Accuracy ;Sensitivity;Specificity;

Secondary

MeasureTime frame
Positive predicative value;negative predictive value;Pathogenic distribution;

Countries

China

Contacts

Public ContactPanwen Tian

West China Hospital of Sichuan University

mrascend@163.com+86 189 8060 6625

Outcome results

None listed

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