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

NCT04955821 | Not Yet Recruiting

• 1 other identifier: fdpicu-22
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

VAP - Ventilator Associated Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

VAP group

Children with respiratory tract infection by mechanical ventilation

Diagnostic Test: mNGS diagnose of VAP

Interventions

mNGS diagnose of VAP DIAGNOSTIC_TEST

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.

VAP group

Eligibility Criteria

• Age: 29 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children receiving invasive mechanical ventilation in PICU

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Biospecimen

Retention: SAMPLES WITH DNA

Sputum specimen

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guoping Lu, doctor

  Children's Hospital of Fundan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gangfeng Yan, doctor

CONTACT

8615900603082; jinyi036@126.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 9, 2021
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share