Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-01-02 @ 3:58 AM
Study NCT ID:
NCT07026656
Status:
RECRUITING
Last Update Posted:
2025-08-03
First Post:
2025-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre-clinical Diagnosis Using Integrated Microbial and Host Response Signatures to Improve Outcomes From Ventilator-associated Pneumonia in Critically Ill Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053717', 'term': 'Pneumonia, Ventilator-Associated'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}], 'ancestors': [{'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}, {'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Endotracheal Aspirate Oropharyngeal Swab Heparinized Blood PAXgene Whole Blood In Cytodelic Stabilizer'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2025-06-10', 'studyFirstSubmitQcDate': '2025-06-17', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characterise temporal shifts in microbial composition and the corresponding host immune response during prolonged mechanical ventilation', 'timeFrame': '3 years', 'description': '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.'}, {'measure': 'Characterise the AMR burden in VAP and its role in shaping the microbiome during infection.', 'timeFrame': '3 years', 'description': 'Utilise metagenomic sequencing to identify AMR genes present on microbes and relate this to VAP development'}, {'measure': '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', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Prevalence of VAP', 'timeFrame': '3 years', 'description': 'Number of critically ill children requiring mechanical ventilation who develop VAP compared to those who do not'}, {'measure': '30 day mortality', 'timeFrame': '3 years', 'description': 'Mortality status of patients at 30 days'}, {'measure': 'Time To Extubation', 'timeFrame': '3 years', 'description': 'Total Time Intubated'}, {'measure': 'Utilisation Of VAP Prevention Bundle', 'timeFrame': '3 years'}, {'measure': 'Culture Results', 'timeFrame': '3 years', 'description': 'Microbiological Results For Each Patient'}, {'measure': 'Days free of antimicrobial therapy in PICU at 7 days', 'timeFrame': '3 years', 'description': 'Days free of antimicrobial therapy during the first 7 days of a patients admission to PICU'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Respiratory Tract Infection', 'Immunology', 'Genomics', 'Paediatric Intensive Care Unit (PICU)'], 'conditions': ['Ventilator Associated Pneumonia ( VAP)']}, 'descriptionModule': {'briefSummary': '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.\n\nDespite 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).\n\nTo 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '1 Month', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Critically Ill Children Requiring Mechanical Ventilation For Greater Than 48 Hours', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PICU Admission\n* Requires 48 Hours Of Mechanical Ventilation\n\nExclusion Criteria:\n\n* Imminent death or palliative care pathway planned\n* Existing tracheostomy at time of admission\n* Known immunocompromised patient\n* Patient received a full course of systemic antimicrobials in the previous 6 weeks.\n* Known or suspected tuberculosis (TB).'}, 'identificationModule': {'nctId': 'NCT07026656', 'acronym': 'VAP-Dx', 'briefTitle': 'Pre-clinical Diagnosis Using Integrated Microbial and Host Response Signatures to Improve Outcomes From Ventilator-associated Pneumonia in Critically Ill Children', 'organization': {'class': 'OTHER', 'fullName': 'University of Cambridge'}, 'officialTitle': 'Pre-clinical Diagnosis Using Integrated Microbial and Host Response Signatures to Improve Outcomes From Ventilator-associated Pneumonia in Critically Ill Children', 'orgStudyIdInfo': {'id': 'IRAS number: 333103'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ventilator Associated Pneumonia Group', 'description': 'Critically ill children who develop VAP during their PICU journey will be assigned to the VAP group'}, {'label': 'Non-Ventilator Associated Pneumonia Group', 'description': 'All patients who fit eligibility criteria for study and do not go on to develop VAP'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CB2 0QQ', 'city': 'Cambridge', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Nazima Pathan, FRCPCH PhD', 'role': 'CONTACT', 'email': 'np409@medschl.cam.ac.uk', 'phone': '+441223 805000'}], 'facility': 'Cambridge University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}], 'centralContacts': [{'name': 'Nazima Pathan, FRCPCH PhD', 'role': 'CONTACT', 'email': 'np409@medschl.cam.ac.uk', 'phone': '+441223 805000'}, {'name': 'Don Laing, MBChB, BMedSci (Hons)', 'role': 'CONTACT', 'email': 'dml57@cam.ac.uk', 'phone': '+441223 805000'}], 'overallOfficials': [{'name': 'Nazima Pathan, FRCPCH PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Paediatrics, University of Cambridge'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cambridge', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cambridge University Hospitals NHS Foundation Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'FRCPCH PhD', 'investigatorFullName': 'Nazima Pathan', 'investigatorAffiliation': 'University of Cambridge'}}}}