VAP - Ventilator Associated PneumoniaNCT04955821
Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
An observational study of VAP - Ventilator Associated Pneumonia, run by Children's Hospital of Fudan University.
Trial 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. Read more about this study
- Who is it for?
- Ages 29 days to 18 years
- Conditions the study is for
- VAP - Ventilator Associated Pneumonia
- What is being tested?
- mNGS diagnose of VAP
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children receiving invasive mechanical ventilation in PICU
Who may be able to join
- 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
Who cannot join
- Participants in other clinical trials in the same period No Informed Consent signed
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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).
Read the 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.
- Conditions
- VAP - Ventilator Associated Pneumonia
- Being tested
- mNGS diagnose of VAP
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mNGS diagnose of VAPDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| VAP group | Children with respiratory tract infection by mechanical ventilation Receives: Diagnostic Test: mNGS diagnose of VAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 28 days after being discharged from PICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start1 Jan 2027 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VAP - Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guoping Lu, doctor, Principal investigator, Children's Hospital of Fundan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955821
- Sponsor's protocol ID
- fdpicu-22
- Status last verified
- Oct 2026
- First submitted
- 5 Jul 2021
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using Metagenomics Next Generation Sequencing
- ClinicalTrials.gov ID
- NCT04955821
- Acronym / sponsor ID
- fdpicu-22
- Conditions
- VAP - Ventilator Associated Pneumonia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 9 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VAP group | – | Diagnostic Test: mNGS diagnose of VAPChildren with respiratory tract infection by mechanical ventilation |
Who may qualify
- Ages
- 29 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children receiving invasive mechanical ventilation in PICU
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Participants in other clinical trials in the same period No Informed Consent signed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mNGS diagnose of VAPThis 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. | Diagnostic test | VAP group |
Primary outcome
The accuracy of mNGS diagnosis in identification of pathogens in children with VAP.
Time frame: within 28 days after being discharged from PICU
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guoping Lu, doctor principal investigator
Children's Hospital of Fundan University
Questions about this trial
What is this clinical trial studying?
An observational study of VAP - Ventilator Associated Pneumonia, run by Children's Hospital of Fudan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gangfeng Yan, doctor (8615900603082, jinyi036@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy of mNGS diagnosis in identification of pathogens in children with VAP. (time frame: within 28 days after being discharged from PICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.