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

RecruitingOBSERVATIONAL
Enrollment

104

Participants

Timeline

Start Date

January 1, 2023

Primary Completion Date

May 1, 2025

Study Completion Date

January 1, 2026

Conditions
Immune Checkpoint Inhibitor Associated Pneumonia
Interventions
DIAGNOSTIC_TEST

Bronchoalveolar lavage and pathogen metagenomic sequencing

After the patient is enrolled, traditional pathogen testing will be improved, and the clinical physician will make a preliminary diagnosis based on routine pathogen testing, clinical manifestations, infection indicators, and imaging. Within 24 hours of initial diagnosis, bronchoalveolar lavage and pathogen metagenomic sequencing were performed, and BALF mNGS results were fed back to clinical physicians (without interfering with clinical decision-making). Clinical treatment data of patients were collected at 72 hours, 7 days, 14 days, and 28 days after the start of treatment, and follow-up and efficacy evaluation were conducted. Finally, a review committee consisting of two senior respiratory physicians and one imaging physician conducted a systematic review of cases to make the final diagnosis of enrolled patients (as the gold standard), analyzing the accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of BALF mNGS in diagnosing CIP.

Trial Locations (1)

Unknown

RECRUITING

Southern Medical University Nanfang Hospital, Guangzhou

All Listed Sponsors
lead

Nanfang Hospital, Southern Medical University

OTHER