Ventilator Associated Pneumonia ( VAP)VAP-DxNCT07026656
Pre-clinical Diagnosis Using Integrated Microbial and Host Response Signatures to Improve Outcomes From Ventilator-associated Pneumonia in Critically Ill Children
An observational study of Ventilator Associated Pneumonia ( VAP), run by University of Cambridge at 1 site in United Kingdom.
Trial summary
Ventilator-associated pneumonia (VAP), defined as pneumonia occurring 48 hours after initiation of invasive mechanical ventilation, is insidious in onset and severe in consequence. It is a critical issue affecting 10-20% of the 26,000 children admitted to the paediatric intensive care unit (PICU) each year. Read more about this study
- Who is it for?
- Ages 1 month to 16 years
- Conditions the study is for
- Ventilator Associated Pneumonia ( VAP)
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Apr 2025to 30 Sep 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 1 month to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Critically Ill Children Requiring Mechanical Ventilation For Greater Than 48 Hours
Who may be able to join
- PICU Admission
- Requires 48 Hours Of Mechanical Ventilation
Who cannot join
- Imminent death or palliative care pathway planned
- Existing tracheostomy at time of admission
- Known immunocompromised patient
- Patient received a full course of systemic antimicrobials in the previous 6 weeks.
- Known or suspected tuberculosis (TB).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
Nazima Pathan, FRCPCH PhD, +441223 805000, np409@medschl.cam.ac.uk
About this study
Ventilator-associated pneumonia (VAP), defined as pneumonia occurring 48 hours after initiation of invasive mechanical ventilation, is insidious in onset and severe in consequence. It is a critical issue affecting 10-20% of the 26,000 children admitted to the paediatric intensive care unit (PICU) each year. Infection typically leads to extended PICU stay, prolonged invasive mechanical ventilation, and increased mortality.
Despite its clinical significance, VAP remains poorly defined, as current diagnosis relies on non-specific criteria and the ability to obtain clinically meaningful cultures. VAP, deviates from conventional pneumonia, potentially originating, from tissue damage, changes to immune processes, and migration of gastrointestinal bacteria into the lung; all associated with prolonged mechanical ventilation. These factors, in combination with the clinical instability of PICU patients, mean that clinicians aggressively start antibiotic therapy despite a paucity of evidence to suggest the best regime. As a result, suspected VAP has been shown to account for nearly 40% of antibiotic exposure in the PICU, which has significant implications on anti-microbial resistance (AMR).
To address these challenges, novel diagnostic therapies are needed to optimise the treatment of VAP. These therapies should utilise our current understanding of the pathophysiology of VAP development, specifically, the infiltration of the lung microbiome by gut and oral bacteria during prolonged mechanical ventilation. To achieve this, molecular testing should be promoted allowing for rapid identification of lung pathogens. There is also growing evidence, for the investigation of predictive biomarkers for VAP available in both the blood and lungs, which when integrated into protocols may enhance diagnostic accuracy. These novel techniques may improve clinical outcomes for affected children while addressing the economic impact of prolonged hospital stays and mitigating AMR risks in PICUs.
- Conditions
- Ventilator Associated Pneumonia ( VAP)
- Keywords
- Respiratory Tract Infection, Immunology, Genomics, Paediatric Intensive Care Unit (PICU)
- Medical subject headings
- Pneumonia, Ventilator-Associated, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ventilator Associated Pneumonia Group | Critically ill children who develop VAP during their PICU journey will be assigned to the VAP group | |
| Non-Ventilator Associated Pneumonia Group | All patients who fit eligibility criteria for study and do not go on to develop VAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterise temporal shifts in microbial composition and the corresponding host immune response during prolonged mechanical ventilation
Serial metagenomic profiling of the lung microbiome to establish microbial shifts. Concurrently, cytokines collected from blood and endotracheal aspirates will be taken to assess immune changes.
Measured: 3 years
Characterise the AMR burden in VAP and its role in shaping the microbiome during infection.
Utilise metagenomic sequencing to identify AMR genes present on microbes and relate this to VAP development
Measured: 3 years
Develop statistical and/or machine learning models leveraging these signatures independently, or in combination, to identify putative microbial and host biomarkers for early VAP diagnosis
Measured: 3 years
Secondary outcomes (6)
Prevalence of VAP
Number of critically ill children requiring mechanical ventilation who develop VAP compared to those who do not
Measured: 3 years
30 day mortality
Mortality status of patients at 30 days
Measured: 3 years
Time To Extubation
Total Time Intubated
Measured: 3 years
Utilisation Of VAP Prevention Bundle
Measured: 3 years
Culture Results
Microbiological Results For Each Patient
Measured: 3 years
Days free of antimicrobial therapy in PICU at 7 days
Days free of antimicrobial therapy during the first 7 days of a patients admission to PICU
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start14 Apr 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated Pneumonia ( VAP)Studies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust
- Responsible party
- Principal investigator, Nazima Pathan, University of Cambridge
- Investigators
- Nazima Pathan, FRCPCH PhD, Principal investigator, Department of Paediatrics, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026656
- Sponsor's protocol ID
- IRAS number: 333103
- Acronym
- VAP-Dx
- Status last verified
- Jul 2025
- First submitted
- 10 Jun 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient data will be collected and stored on REDcap Safe Haven. All data that is shared will be anonymised to ensure it is not identifiable.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-clinical Diagnosis Using Integrated Microbial and Host Response Signatures to Improve Outcomes From Ventilator-associated Pneumonia in Critically Ill Children
- ClinicalTrials.gov ID
- NCT07026656
- Acronym / sponsor ID
- VAP-Dx / IRAS number: 333103
- Conditions
- Ventilator Associated Pneumonia ( VAP)
- Keywords
- Respiratory Tract Infection, Immunology, Genomics, Paediatric Intensive Care Unit (PICU)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 18 Jun 2025 (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.
Ventilator-associated pneumonia (VAP), defined as pneumonia occurring 48 hours after initiation of invasive mechanical ventilation, is insidious in onset and severe in consequence. It is a critical issue affecting 10-20% of the 26,000 children admitted to the paediatric intensive care unit (PICU) each year. Infection typically leads to extended PICU stay, prolonged invasive mechanical ventilation, and increased mortality.
Despite its clinical significance, VAP remains poorly defined, as current diagnosis relies on non-specific criteria and the ability to obtain clinically meaningful cultures. VAP, deviates from conventional pneumonia, potentially originating, from tissue damage, changes to immune processes, and migration of gastrointestinal bacteria into the lung; all associated with prolonged mechanical ventilation. These factors, in combination with the clinical instability of PICU patients, mean that clinicians aggressively start antibiotic therapy despite a paucity of evidence to suggest the best regime. As a result, suspected VAP has been shown to account for nearly 40% of antibiotic exposure in the PICU, which has significant implications on anti-microbial resistance (AMR).
To address these challenges, novel diagnostic therapies are needed to optimise the treatment of VAP. These therapies should utilise our current understanding of the pathophysiology of VAP development, specifically, the infiltration of the lung microbiome by gut and oral bacteria during prolonged mechanical ventilation. To achieve this, molecular testing should be promoted allowing for rapid identification of lung pathogens. There is also growing evidence, for the investigation of predictive biomarkers for VAP available in both the blood and lungs, which when integrated into protocols may enhance diagnostic accuracy. These novel techniques may improve clinical outcomes for affected children while addressing the economic impact of prolonged hospital stays and mitigating AMR risks in PICUs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ventilator Associated Pneumonia Group | – | –Critically ill children who develop VAP during their PICU journey will be assigned to the VAP group |
| Non-Ventilator Associated Pneumonia Group | – | –All patients who fit eligibility criteria for study and do not go on to develop VAP |
Who may qualify
- Ages
- 1 month to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Critically Ill Children Requiring Mechanical Ventilation For Greater Than 48 Hours
Key inclusion criteria (2 listed)
- PICU Admission
- Requires 48 Hours Of Mechanical Ventilation
Key exclusion criteria (5 listed)
- Imminent death or palliative care pathway planned
- Existing tracheostomy at time of admission
- Known immunocompromised patient
- Patient received a full course of systemic antimicrobials in the previous 6 weeks.
- Known or suspected tuberculosis (TB).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characterise temporal shifts in microbial composition and the corresponding host immune response during prolonged mechanical ventilation
Time frame: 3 years
Serial metagenomic profiling of the lung microbiome to establish microbial shifts. Concurrently, cytokines collected from blood and endotracheal aspirates will be taken to assess immune changes.
Characterise the AMR burden in VAP and its role in shaping the microbiome during infection.
Time frame: 3 years
Utilise metagenomic sequencing to identify AMR genes present on microbes and relate this to VAP development
Develop statistical and/or machine learning models leveraging these signatures independently, or in combination, to identify putative microbial and host biomarkers for early VAP diagnosis
Time frame: 3 years
6 secondary outcomes
Prevalence of VAP
Time frame: 3 years
30 day mortality
Time frame: 3 years
Time To Extubation
Time frame: 3 years
Utilisation Of VAP Prevention Bundle
Time frame: 3 years
Culture Results
Time frame: 3 years
Days free of antimicrobial therapy in PICU at 7 days
Time frame: 3 years
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 3 Aug 2025.
- Individual participant dataSharing planned: No. Patient data will be collected and stored on REDcap Safe Haven. All data that is shared will be anonymised to ensure it is not identifiable.
Related trials for Ventilator Associated Pneumonia ( VAP)
Not yet recruitingObservational study
Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
Recruiting
Immediate Versus Substantiated Antibiotic Therapy in Suspected Non-Severe Ventilator-Associated Pneumonia
Ventilator-Associated Pneumonia (VAP)
Recruiting
Effect of Ventilator Hyperinflation Combined With Body Positioning on ABG in VAP
Ventilator Associated Bacterial Pneumonia (VABP), Critical Illness
Active, not recruiting
HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Array
HAP - Hospital Acquired Pneumonia, VAP - Ventilator Associated Pneumonia
RecruitingPhase 4
Combined Use of a Respiratory Multiplex PCR and Algorithm-based Therapy to Improve Early Optimization of Antibiotic Therapy in Critically Ill Patients With Ventilator-associated Pneumonia
Ventilator Associated Pneumonia ( VAP)
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.
Nazima Pathan, FRCPCH PhD principal investigator
Department of Paediatrics, University of Cambridge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator Associated Pneumonia ( VAP), run by University of Cambridge at 1 site in United Kingdom.
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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Nazima Pathan, FRCPCH PhD (+441223 805000, np409@medschl.cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterise temporal shifts in microbial composition and the corresponding host immune response during prolonged mechanical ventilation (time frame: 3 years). The study lists 3 primary outcomes in all. 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 3 Aug 2025.