Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS

Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using Metagenomics Next Generation Sequencing

VAP（Ventilator-associated pneumonia）is the most common complication of mechanical ventilation in severely ill patients. VAP is defined as pneumonia occurring 48 hours after patients receive mechanical ventilation, including pneumonia occurring within 48 hours after extubation. It is one of the important causes of hospital-acquired infection, and the incidence of VAP in children on mechanical ventilation is about 10%, or 7/1000 days of mechanical ventilation, and the overall mortality is 10-24%.Research has so far explained the relationship between bacteria isolated from human biological samples and VAP pathogens. Most studies are limited to the level of bacterial species, and there are few reports on bacterial genotyping, and there is a lack of scientific basis for the pathogenesis of VAP caused by bacteria in ventilator pipeline. The aim of the study is to investigate pathogen of the sputum in deep respiratory tract of patients with mechanical ventilation in PICU by the means of second generation sequencing (NGS).

Study Overview

• Status: Not yet recruiting
• Conditions: VAP - Ventilator Associated Pneumonia
• Intervention / Treatment: Diagnostic test: mNGS diagnose of VAP

Detailed Description

Children receiving invasive mechanical ventilation in the intensive care unit (PICU) of the Pediatric Hospital of Fudan University will be included. Deep sputum samples were collected within 24 h and on day 5 of mechanical ventilation, respectively, and sent for NGS at the same time. Sputum etiology examination is performed with sputum culture blood free DNA test.

The basic clinical data of the children (age, sex, weight, PICU diagnosis and other basic information, as well as the time of start and end of invasive mechanical ventilation for basic diseases, Glasgow coma score (GCS score), 3rd generation pediatric mortality risk score III(Prism III score), CRP, PCT, white blood cell count and body temperature will be recorded。 Clinical data related to the use of glucocorticoids, antibiotics and other drugs as well as life support such as renal replacement therapy, extracorporeal membrane, lung oxygenation and other life support were collected. Time and method of diagnosis of VAP pathogens were collected.

By comparing sensitivity and specificity of NGS and conventional sputum specimens for detection of VAP, the clinical value of mNGS in VAP will be studied.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Gangfeng Yan, doctor; Phone Number: 8615900603082; Email: jinyi036@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children receiving invasive mechanical ventilation in PICU

Description

Inclusion Criteria:

• The time of invasive mechanical ventilation was less than 24 h when admitted to PICU Total duration of invasive mechanical ventilation is over 5 days

Exclusion Criteria:

• Participants in other clinical trials in the same period No Informed Consent signed

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
VAP group; Children with respiratory tract infection by mechanical ventilation	Diagnostic test: mNGS diagnose of VAP; This study is an observational study to evaluate the accuracy of pathogens in children with VAP tested by mNGS with no intervention. All patients from the cohort accept mNGS test and bacterial culture or virus PCR detection. A double sputum specimens are used for test.The reference standard is bacterial culture or virus PCR detection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The accuracy of mNGS diagnosis in identification of pathogens in children with VAP.	The accuracy of combined diagnosis includes sensitivity and specificity. The reference standard test ( bacterial culture or virus PCR detection) and mNGS diagnosis are conducted in the cohort of pediatric children diagnosed of VAP	within 28 days after being discharged from PICU

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University
• Investigators: Principal Investigator: Guoping Lu, doctor, Children's Hospital of Fundan University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 5, 2021
• First Submitted That Met QC Criteria: July 5, 2021
• First Posted (Actual): July 9, 2021

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Healthcare-Associated Pneumonia; Pathologic Processes; Disease Attributes; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Cross Infection; Iatrogenic Disease; Pathological Conditions, Signs and Symptoms; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: fdpicu-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No