Skip to content

Prospective study on the efficacy and safety of bronchoalveolar lavage combined with pathogen metagenomic sequencing technology in the diagnosis of immune checkpoint inhibitor associated pneumonia

Prospective study on the efficacy and safety of bronchoalveolar lavage combined with pathogen metagenomic sequencing technology in the diagnosis of immune checkpoint inhibitor associated pneumonia

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300076258
Enrollment
Unknown
Registered
2023-09-28
Start date
2023-07-01
Completion date
Unknown
Last updated
2023-10-03

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

Conditions

Immune checkpoint inhibitor associated pneumonia

Interventions

Gold Standard:Reference criteria: 1. History of immunotherapy (patient has received 1CIs treatment) 2. Imaging manifestations: New positive lung shadows (such as ground glass shadows, patchy consolida
Index test:High throughput sequencing technology (NGS) combined with alveolar lavage surgery

Sponsors

Southern Medical University Southern Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily sign an informed consent form; 2. Age range from 18 to 75 years old, regardless of gender; 3. Immunosuppressive host; 4. Symptoms, signs, or imaging signs of pneumonia are visible, and empirical anti infection treatment is ineffective.

Exclusion criteria

Exclusion criteria: 1. Failure to complete microscopic examination and culture of alveolar lavage fluid or sputum; 2. The researcher believes that there are any individuals who are not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Bronchoalveolar lavage combined with pathogen metagenomic sequencing;Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), accuracy;

Secondary

MeasureTime frame
Blood routine;Sputum/alveolar lavage fluid G/GM test;Chest CT;Characteristics of peripheral blood lymphocyte subpopulations;Cytokine assay;

Countries

China

Contacts

Public ContactLiu Laiyu

Southern Medical University Southern Hospital

liulaiyu@126.com+86 136 3210 2245

Outcome results

None listed

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