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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age29-18
SponsorChildren's Hospital of Fudan University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Children receiving invasive mechanical ventilation in PICU

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

400 Participants
are divided into 1 treatment group
Group A: VAP group1 intervention

Trial outcomes

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

Time frame
within 28 days after being discharged from PICU

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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