Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-27 @ 11:23 PM
Study NCT ID:
NCT06073834
Status:
RECRUITING
Last Update Posted:
2025-02-12
First Post:
2023-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LUNG INFECTION in ICU (LUNG-I3)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053717', 'term': 'Pneumonia, Ventilator-Associated'}, {'id': 'D018805', 'term': 'Sepsis'}], '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'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Four types of samples are taken for the study per patient at day 4 after ICU admission:\n\n* whole blood collected in a PAXgene tube\n* dry tube for serum biobank\n* lithium heparin tube for plasma biobank\n* bronchoalveolar Lavage'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-10', 'studyFirstSubmitDate': '2023-10-03', 'studyFirstSubmitQcDate': '2023-10-03', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'immune cells patterns in VAP', 'timeFrame': 'before and at time of VAP diagnosis', 'description': 'The primary endpoint will be to describe and compare the distribution of immune cells within the lung and the blood before VAP diagnosis (VAP prediction) and at the time of VAP diagnosis.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['VAP - Ventilator Associated Pneumonia', 'Sepsis', 'Lung Infection', 'Broncho-alveolar Lavage', 'ICU'], 'conditions': ['VAP - Ventilator Associated Pneumonia']}, 'descriptionModule': {'briefSummary': 'objective of LUNG-I3 study is to assess the quantitative and functional differences in cells between blood and bronchoalveolar lavage (BAL) fluid after an infection, with a special focus on alveolar macrophages and neutrophils'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'ICU Adult patients hospitalized and managed for septic shock or severe trauma (including severe burn) and undergoing mechanical ventilation (within 24h of admission) with an expected length upper than 3 days.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll the following criteria\n\n* Age 18 years or greater\n* Severe ICU patients hospitalized for one of the above diseases:\n\n * Septic shock (requirement of vasopressor to maintain a mean arterial pressure of 65 mm Hg or greater and serum lactate level greater than 2 mmol/L (\\>18 mg/dL) in the absence of hypovolemia) caused either by pneumonia (n=20) or another source n=20)\n * Severe trauma (level I and II), Injury Severity Score ≥ 25 OR\n * Burn with TBSA over 20%\n* NAD \\> 0.1 µg/kg/min\n* At least 2 SOFA criteria ≥ 2 points\n\nExclusion Criteria:\n\n* Aspiration pneumonia\n* Unable to obtain a valid and written consent from a patient or their legally authorized representative in accordance with the local regulatory instances (this includes in FR: Person not affiliated to a health insurance scheme, or not a beneficiary of such a scheme. Persons who are the subject of a legal protection order. Person with restricted freedom following a legal or administrative decision and a person admitted without their consent pursuant to Articles L.3212-1 and 3213-1, which are not included in Article L.1121-8 of the French Public Health Code.)\n* COPD\n* Smoke inhalation in burn patients\n* Participation in an intervention study\n* Pregnant or breastfeeding women\n* Immunocompromised patients, defined as\n\n * patients with solid tumors with chemotherapy in the last 3 months or a progressive metastatic disease\n * hematologic malignancies\n * solid organ transplantation\n * HIV infection with or without AIDS\n * treatment with corticosteroids (\\> 3 months at any dosage or ≥ 1 mg/kg prednisone equivalent per day for \\> 7 day)\n * treatment with other immunosuppressive drugs.'}, 'identificationModule': {'nctId': 'NCT06073834', 'acronym': 'LUNG-I3', 'briefTitle': 'LUNG INFECTION in ICU (LUNG-I3)', 'organization': {'class': 'INDUSTRY', 'fullName': 'BioMérieux'}, 'officialTitle': 'LUNG INFECTION in ICU', 'orgStudyIdInfo': {'id': 'LUNG-I3'}}, 'contactsLocationsModule': {'locations': [{'zip': '69003', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne-Claire Lukaszewicz, PU-PH', 'role': 'CONTACT'}], 'facility': 'Hopital Edouard Herriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'centralContacts': [{'name': 'Jean-François LLITJOS', 'role': 'CONTACT', 'email': 'jeanfrancois.llitjos@biomerieux.com', 'phone': '+33761568397'}, {'name': 'Marie-Angelique CAZALIS', 'role': 'CONTACT', 'email': 'marie-angelique.cazalis@biomerieux.com', 'phone': '+33626807839'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BioMérieux', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}