Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2025-12-25 @ 11:12 PM
Study NCT ID:
NCT04926493
Status:
UNKNOWN
Last Update Posted:
2021-06-15
First Post:
2021-05-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Structural and Microbiological Characterization of Endotracheal Tube Biofilm in Patients at Increased Risk for the Development of Ventilator-associated Pneumonia in the Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053717', 'term': 'Pneumonia, Ventilator-Associated'}], 'ancestors': [{'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}, {'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 61}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-08', 'studyFirstSubmitDate': '2021-05-27', 'studyFirstSubmitQcDate': '2021-06-08', 'lastUpdatePostDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development of Ventilator-associated pneumonia (VAP)', 'timeFrame': 'Immediately after extubation of the patient', 'description': 'Provide a better understanding of the correlation between structural and microbiological characterization of endotracheal tube biofilm in critically ill patients and increased risk for the development of VAP in ICU during COVID-19 pandemic.'}], 'secondaryOutcomes': [{'measure': 'Development of other VAP, healthcare-associated infection (HAI) or mortality', 'timeFrame': 'Immediately after extubation of the patient', 'description': 'Provide a better understanding of the correlation between structural and microbiological characterization of endotracheal tube biofilm in critically ill patients and increased risk for the development of other VAP, healthcare-associated infection (HAI) or mortality in ICU during COVID-19 pandemic.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Biofilm Formation', 'Structural and Microbiological Characterization of Endotracheal Tube Biofilm', 'Ventilator-associated Pneumonia (VAP)']}, 'referencesModule': {'references': [{'pmid': '36575298', 'type': 'DERIVED', 'citation': "Maldiney T, Pineau V, Neuwirth C, Ouzen L, Eberl I, Jeudy G, Dalac S, Piroth L, Blot M, Sautour M, Dalle F, Abdulmalak C, Ter Schiphorst R, Pugliesi PS, Poussant T, Ogier-Desserrey A, Fournel I, de Giraud d'Agay M, Jacquier M, Labruyere M, Aptel F, Roudaut JB, Vieille T, Andreu P, Prin S, Charles PE, Hamet M, Quenot JP. Endotracheal tube biofilm in critically ill patients during the COVID-19 pandemic : description of an underestimated microbiological compartment. Sci Rep. 2022 Dec 27;12(1):22389. doi: 10.1038/s41598-022-26560-w."}]}, 'descriptionModule': {'briefSummary': 'Ventilator-associated pneumonia (VAP) remains the most frequent healthcare-associated infection (HAI) in the intensive care unit (ICU) and one of the most critical risk factors associated with both significant morbidity as well as mortality. Although VAP treatment relies on early and appropriate antimicrobial therapy, several preventive measures have been described in the literature in order to limit its incidence and clinical impact in the ICU. Among these, preventing biofilm formation on the inner surface of the endotracheal tube appears to hold promise. Yet there is a lack of clinical relevant data documenting a causal relation between biofilm formation and VAP. Designed to overcome this critical limitation, the BIOPAVIR study intends to provide a better structural and microbiological characterization of endotracheal tube biofilm in critically ill patients at increased risk for the development of VAP in ICU during COVID-19 pandemic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patient \\> 18 years of age with mechanical ventilation for \\>2 calendar days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient \\> 18 years of age with mechanical ventilation for \\>2 calendar days\n\nExclusion Criteria:\n\n* inability to collect or dispatch the endotracheal tube for proper characterization within 24 hours post-extubation'}, 'identificationModule': {'nctId': 'NCT04926493', 'acronym': 'BIOPAVIR', 'briefTitle': 'Structural and Microbiological Characterization of Endotracheal Tube Biofilm in Patients at Increased Risk for the Development of Ventilator-associated Pneumonia in the Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Structural and Microbiological Characterization of Endotracheal Tube Biofilm in Patients at Increased Risk for the Development of Ventilator-associated Pneumonia in the Intensive Care Unit', 'orgStudyIdInfo': {'id': 'QUENOT-Maldiney 2021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BIOPAVIR Cohort', 'description': 'Critically ill patient \\> 18 years of age with mechanical ventilation for \\>2 calendar days, at increased risk for the development of Ventilator-Associated Pneumonia in the Intensive Care Unit during COVID-19 pandemic.', 'interventionNames': ['Biological: microbiological characterization']}], 'interventions': [{'name': 'microbiological characterization', 'type': 'BIOLOGICAL', 'description': 'microbiological characterization of endotracheal tube biofilm', 'armGroupLabels': ['BIOPAVIR Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Pierre QUENOT', 'role': 'CONTACT', 'email': 'jean-pierre.quenot@chu-dijon.fr', 'phone': '03.80.29.36.85'}], 'facility': 'CHU Dijon Bourgogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}], 'centralContacts': [{'name': 'Jean Pierre QUENOT', 'role': 'CONTACT', 'email': 'jean-pierre.quenot@chu-dijon.fr', 'phone': '03.80.29.36.85'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}