Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-01-01 @ 6:17 PM
Study NCT ID:
NCT05089968
Status:
COMPLETED
Last Update Posted:
2021-10-22
First Post:
2021-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ventilation Associated Pneumonia and Covid-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D053717', 'term': 'Pneumonia, Ventilator-Associated'}, {'id': 'D055371', 'term': 'Acute Lung Injury'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}, {'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D055370', 'term': 'Lung Injury'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 268}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-01-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-21', 'studyFirstSubmitDate': '2021-10-21', 'studyFirstSubmitQcDate': '2021-10-21', 'lastUpdatePostDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAP ecological difference between the first and second waves of COVID', 'timeFrame': 'January 2020 to January 2021', 'description': 'Proportion of patients admitted to critical care with documented multidrug-resistant bacteria (MDR) VAP in Covid-19 wave 1 and 2'}], 'secondaryOutcomes': [{'measure': 'proportion of fungal co-infections', 'timeFrame': 'January 2020 to January 2021', 'description': 'Comparison of the proportion of patients with a fungal infection during the 1st and 2nd wave'}, {'measure': 'duration of mechanical ventilation', 'timeFrame': 'Day 28', 'description': 'Number of days under mechanical ventilations'}, {'measure': 'number of days of organ failure', 'timeFrame': 'Day 28', 'description': 'number of days between first organ failure and no organ failure (discharge from intensive care)'}, {'measure': 'Mortality', 'timeFrame': 'Day 28', 'description': 'proportion of patients deceased at day 28'}, {'measure': 'proportion of patients treated with corticosteroid therapy', 'timeFrame': 'Day 28', 'description': 'proportion of patients treated with corticosteroid therapy'}, {'measure': 'probabilistic antibiotic therapy at admission', 'timeFrame': 'Day 1', 'description': 'probabilistic antibiotic therapy prescribed at admission'}, {'measure': 'antiviral treatment', 'timeFrame': 'Day 28', 'description': 'proportion of patients treated with antiviral treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intensive care Unit', 'multidrug resistance', 'COVID 19 ARDS', 'ventilator associated pneumonia', 'SARS-CoV2 Infection'], 'conditions': ['SARS-CoV2 Infection', 'Ventilator Associated Pneumonia', 'Ards', 'COVID-19']}, 'descriptionModule': {'briefSummary': 'In December 2019, a new pandemic emerged, the COVID-19 disease caused by a SARS-Cov-2 virus. One of the most common symptoms of COVID-19 is mainly respiratory failure and patients requires assistance by mechanical ventilation. Ventilator-associated pneumonia (VAP) is a risk of this assistance. Since the beginning of the pandemic, Standard of care have evolved with new data. The prevalence of these VAPs seems significantly higher in the population of patients with ARDS COVID-19 (40-50%) and their ecology seems to have evolved over time, particularly in terms of bacterial resistance. Investigators want to describe and compare this evolution of bacterial and fungal ecology as well as identify potential risk factors that may be associated with these changes in ecology during different waves.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients over 18 years old with a SARS-CoV-2 infection confirmed by positive PCR tests of nasopharyngeal or respiratory secretion samples. In addition, patients included presented a healthcare associated pneumonia according to SFAR(French Society of Anesthesia and Intensive Care) recommendations and based on criteria adapted from the European Centre for Disease Prevention and Control (ECDC) recommendations. Patients who refused their data use were excluded.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Positive SARS-Cov-2 polymerase chain reaction (PCR)\n* healthcare associated pneumonia\n\nExclusion Criteria : Patient opposition to participate to the study'}, 'identificationModule': {'nctId': 'NCT05089968', 'acronym': 'ECOLCOVID', 'briefTitle': 'Ventilation Associated Pneumonia and Covid-19', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Ventilator-associated Pneumonia Ecology Comparison in a French ICU Center NIMES Between First and Second Wave of COVID-19 : a Retrospective Monocentric Descriptive Study', 'orgStudyIdInfo': {'id': 'LOCAL/2021/LC-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient from the first wave of COVID-19', 'description': '57 Patients hospitalized in intensive care unit for pneumonia related to a Sars-Cov2 infection who required mechanical ventilatory support and developed microbiologically documented ventilator associated pneumonia during the 1st wave from January 24, 2020 to July 10, 2020'}, {'label': 'Patient from the Second wave of COVID-19', 'description': '211 Patients hospitalized in intensive care unit for pneumonia related to a Sars-Cov2 infection who required mechanical ventilatory support and developed microbiologically documented ventilator associated pneumonia during the 2nd wave from July 11, 2020 to January 8, 2021'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU de Nîmes - Hôpital Universitaire Carémeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'overallOfficials': [{'name': 'Claire ROGER, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nîmes'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}