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Application of Targeted Next-Generation Sequencing in the Diagnosis and Treatment of Bronchiectasis with Acute Exacerbations

Application of Targeted Next-Generation Sequencing in the Diagnosis and Treatment of Bronchiectasis with Acute Exacerbations

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500113046
Enrollment
Unknown
Registered
2025-11-24
Start date
2025-11-24
Completion date
Unknown
Last updated
2025-12-01

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

Conditions

Bronchiectasis with acute exacerbation

Interventions

Gold Standard:The final microbiological diagnosis was adjudicated based on a comprehensive clinical and microbiological evaluation, including BALF-tNGS results, conventional microbiological testing (C
Index test:Targeted Next-Generation Sequencing

Sponsors

Department of Respiratory and Critical Care Medicine, Key Laboratory of Respiratory Disease of Ningbo, The First Affiliated Hospital of Ningbo University, Ningbo
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age >=18 years and <=80 years; 2. Chest computed tomography (CT) shows imaging features consistent with bronchiectasis; 3. Meet the diagnostic criteria for acute exacerbation of bronchiectasis, presenting with symptoms such as cough, sputum production, chest tightness, or wheezing, and willing to undergo bronchoscopy with bronchoalveolar lavage fluid (BALF) collection for tNGS testing; 4. Provide written informed consent and voluntarily participate in this clinical study.

Exclusion criteria

Exclusion criteria: 1. Presence of severe cardiopulmonary disease, coagulopathy, poor anesthesia tolerance, or psychiatric or severe neurofunctional disorders that constitute contraindications to bronchoscopy; 2. Intra-procedural desaturation (SpO2 decrease) or intolerance to bronchoscopy, or inability to tolerate further bronchoalveolar lavage despite tolerating bronchoscopy; 3. Inability to cooperate with study procedures for any reason, or deemed unsuitable for inclusion by the investigators for other medical or safety considerations; 4. Visible endobronchial hemorrhage on bronchoscopy suggesting potential risk of clinical deterioration following lavage; 5. Incomplete or missing key clinical information required for study assessment.

Design outcomes

Primary

MeasureTime frame
Diagnostic performance of BALF-tNGS compared with conventional microbiological tests;

Secondary

MeasureTime frame
Turnaround time of BALF-tNGS compared with conventional microbiological tests;Impact of BALF-tNGS and CMT on antimicrobial treatment decisions;Clinical improvement after treatment modification guided by BALF-tNGS and CMT;Pathogen spectrum identified by BALF-tNGS compared with conventional microbiological tests;

Countries

Chian

Contacts

Public ContactChen Zhongbo

Department of Respiratory and Critical Care Medicine, Key Laboratory of Respiratory Disease of Ningbo, The First Affiliated Hospital of Ningbo University, Ningbo

leonczb@163.com+86 137 7712 5910

Outcome results

None listed

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