Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 1:30 AM
Study NCT ID:
NCT06243094
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antibiotic Therapy Practices for Ventilator-Associated Pneumonia (PETUNIA)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000900', 'term': 'Anti-Bacterial Agents'}], 'ancestors': [{'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1060}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-03-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-13', 'studyFirstSubmitDate': '2024-01-19', 'studyFirstSubmitQcDate': '2024-01-27', 'lastUpdatePostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characteristics of Initial Antibiotic Treatment', 'timeFrame': '3 days', 'description': 'Empirical / guided / directly targeted Monotherapy or combination therapy Monotherapy or combination therapy against resistant GNB Addition of an antibiotic active against Methicillin-Resistant Staphylococcus aureus Molecule(s) and class(es) of antibiotics Time from the onset of suspected VAP to initiation of initial antibiotic treatment Total dose in the first 24 hours for each molecule Administration modalities in the first 24 hours for each molecule Conducting plasma level measurements Appropriate treatment (in patients with microbiologically confirmed VAP) Time from the onset of suspected VAP to initiation of appropriate antibiotic treatment (in patients with microbiologically confirmed VAP)\n\nNote for the reviewer: our study is descriptive, and multiple characteristics of initial antibiotic treatment have been validated by the institutional review board and methodologist, as a descriptive outcome.'}, {'measure': 'Characteristics of Definitive Antibiotic Treatment (for patients alive at Day 3 only)', 'timeFrame': '7 days', 'description': 'Monotherapy or combination therapy Molecule(s) and class(es) of antibiotics Broadening of antibiotic spectrum Discontinuation of all antibiotics (prescribed for VAP treatment) at Day 3 and Day 5 Antibiotic de-escalation at Day 3 and Day 5 by reducing the spectrum of an initial antibiotic or by discontinuing a component of an initial combination of antibiotics\n\nNote for the reviewer: our study is descriptive, and multiple characteristics of definite antibiotic treatment have been validated by the institutional review board and methodologist, as a descriptive outcome.'}, {'measure': 'Total Duration of Appropriate Treatment', 'timeFrame': 'ICU stay (up to 28 days)', 'description': 'Total Duration of Appropriate Treatment for the episode of VAP'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['antibiotic', 'intensive care', 'guidelines', 'outcome'], 'conditions': ['Ventilator Associated Pneumonia']}, 'descriptionModule': {'briefSummary': 'The French Society of Intensive Care conducts a comprehensive assessment of current antibiotic therapy practices in critically ill patients suspected of Ventilator-Associated Pneumonia (VAP).', 'detailedDescription': 'This prospective observational multicenter study will be conducted in intensive care units (ICU) across France and French-speaking regions. The primary objective of this study is to delineate the characteristics of antibiotic treatments administered for a first episode of suspected VAP. Secondary objectives include describing the outcomes of enrolled patients, assessing adherence to European guidelines regarding empirical antibiotic treatment, and identifying factors associated with mortality in patients with microbiologically confirmed VAP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants in this study will be ICU patients, undergoing invasive mechanical ventilation \\> 48h, for whom antibiotic therapy is initiated to treat a suspicion of Ventilator-Associated Pneumonia (VAP).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Admission to the ICU\n* Intubation and duration of invasive mechanical ventilation \\> 48 hours\n* Initiation of new antibiotic therapy to treat a first suspicion of Ventilator-Associated Pneumonia (VAP)\n\nExclusion Criteria:\n\n* Presence of a decision to limit active therapeutic measures at the time of initiating antibiotic therapy\n* Organ donor\n* Prior inclusion in the study during a previous stay in the intensive care unit (a patient cannot be included multiple times)\n* Participation in an interventional study focusing on the management of VAP and directly impacting antibiotic therapy practices\n* Patient and/or family opposition to participation\n* Lack of affiliation with a social security system'}, 'identificationModule': {'nctId': 'NCT06243094', 'acronym': 'PETUNIA', 'briefTitle': 'Antibiotic Therapy Practices for Ventilator-Associated Pneumonia (PETUNIA)', 'organization': {'class': 'OTHER', 'fullName': 'French Society for Intensive Care'}, 'officialTitle': 'Survey on Antibiotic Therapy Practices for Ventilator-Associated Pneumonia in ICU Patients', 'orgStudyIdInfo': {'id': '2023-A01492-43'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'microbiologically confirmed VAP', 'description': 'patients who meet ATS/IDSA 2005 VAP criteria with microbiological confirmation', 'interventionNames': ['Drug: Antibiotic']}, {'label': 'non microbiologically confirmed VAP', 'description': 'patients who do not meet ATS/IDSA 2005 criteria with microbiological confirmation', 'interventionNames': ['Drug: Antibiotic']}], 'interventions': [{'name': 'Antibiotic', 'type': 'DRUG', 'otherNames': ['antimicrobial therapy'], 'description': 'All antibiotic therapy characteristics are monitored.', 'armGroupLabels': ['microbiologically confirmed VAP', 'non microbiologically confirmed VAP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59000', 'city': 'Lille', 'state': 'Haut de France', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anahita Rouzé, MD', 'role': 'CONTACT'}, {'name': 'Anahita Rouzé, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lille university hospital', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'centralContacts': [{'name': 'Anahita Rouzé, MD', 'role': 'CONTACT', 'email': 'anahita.rouze@chu-lille.fr', 'phone': '0033 3 20 44 40 84'}], 'overallOfficials': [{'name': 'Anahita Rouzé, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'French Intensive Care Society'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'French Society for Intensive Care', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}