Clinical trial NCT06192303: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Immune Checkpoint Inhibitor Associated Pneumonia
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: Immune checkpoint inhibitor associated pneumonia (CIP) is a common immune related adverse reaction, accounting for 35% of all deaths. However, due to the lack of typical clinical symptoms and imaging manifestations, CIP needs to be differentiated from other diseases such as pulmonary infections and lung cancer progression. Currently, there is a lack of diagnostic gold standards, which belongs to exclusive diagnosis. Empirical diagnosis and treatment in clinical practice can easily lead to the abuse of hormones and antibiotics, and even misdiagnosis and mistreatment, resulting in patient death. Therefore, early identification of CIP and pulmonary infection is the key to successful diagnosis and treatment. The CIP diagnosis and treatment guidelines recommend performing bronchoalveolar lavage as appropriate, but there is still a lack of large-scale prospective clinical studies. The beneficial pathogen metagenomic sequencing technology for the diagnosis of pulmonary infections has not been mentioned. Our research group conducted a prospective clinical study for the first time to evaluate the effectiveness and safety of bronchoalveolar lavage combined with pathogen metagenomic sequencing technology in diagnosing CIP, explore biomarkers for diagnosing CIP, in order to improve the early diagnosis rate and treatment efficiency of CIP, and reduce the abuse of antibiotics and hormones.


Eligibility 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:

Primary outcomes:
measure: Sensitivity, specificity in suspected CIP patients
timeFrame: 2023.01-2026.01
measure: Positive predictive value (PPV), negative predictive value (NPV) in suspected CIP patients
timeFrame: 2023.01-2026.01
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Southern Medical University Nanfang Hospital
state: Guangdong
Study officials:
References: