Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-29 @ 11:31 AM
Study NCT ID:
NCT04359706
Status:
COMPLETED
Last Update Posted:
2022-10-17
First Post:
2020-04-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bacterial and Fungal Microbiota of Patients With Severe Viral Pneumonia With COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'bronchoalveolar lavage and rectal swabs'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-14', 'studyFirstSubmitDate': '2020-04-21', 'studyFirstSubmitQcDate': '2020-04-21', 'lastUpdatePostDateStruct': {'date': '2022-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composition of the fecal bacterial and fungal microbiota', 'timeFrame': 'At 28 days', 'description': 'relative abundances and diversity indices'}], 'secondaryOutcomes': [{'measure': 'Analysis of the faecal microbiota from rectal swab', 'timeFrame': 'at baseline and every 7 days during 28 days', 'description': 'Alterations in fecal microbiota composition (including virose, bacteria and fungi) in COVID-19 patients compared with controls'}, {'measure': 'Analysis of the respiratory microbiota from the bronchoalveolar lavage liquid', 'timeFrame': 'at baseline and every 7 days during 28 days', 'description': 'Alterations in respiratory microbiota composition (including virose, bacteria and fungi) in COVID-19 patients compared with controls'}, {'measure': 'Serum inflammatory markers changes', 'timeFrame': 'at 28 days,', 'description': 'Changes in blood, c-reactive protein, leucocyte, lymphocyte from baseline'}, {'measure': 'Inflammatory markers changes', 'timeFrame': 'at 28 days,', 'description': 'changes in Cytokine/ chemokine from baseline'}, {'measure': 'Mortality', 'timeFrame': 'at 28 days,', 'description': 'death'}, {'measure': 'mechanical ventilation free days', 'timeFrame': 'at 28 days,', 'description': 'Number of days alive without mechanical ventilation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sars-CoV2']}, 'descriptionModule': {'briefSummary': 'Observational pilot single-center study aiming to determine the microbiota of critically ill patients infected with SARS-CoV-2. COVID-19 patients will be compared to historical critically ill controls with no SARS-CoV-2 infection.', 'detailedDescription': 'Observational pilot single-center study aiming to determine the microbiota of critically ill patients infected with SARS-CoV-2. COVID-19 patients will be compared to historical critically ill controls with no SARS-CoV-2 infection.\n\nRespiratory and fecal microbiota (microbial and fungal) will be determined in COVID-19 patients on bronchoalveolar lavage and rectal swab.\n\nInflammatory biomarkers will also be measured in COVID-19 patients.\n\nCharacteristics of study patients will be collected at ICU admission and during ICU stay.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients suspected of SARS-CoV2 infection and admitted in ICU', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor the Covid-19 Group: with a confirmed severe lung infection with CoV2-SARS-Cov2 admitted to the ICU.\n\nFor the Control Group:\n\n* Historic cohort of non SARS -CoV2-infected adults admitted to the ICU (between March and October 2019),\n* that was investigated for fecal microbiota in a previous study (control patients in a fecal microbiota study in patients included in the SEAT study).\n\nExclusion Criteria:\n\n* For the Covid-19 group:\n* Lack of coverage Patients who received antibiotic therapy within 6 weeks prior to Covid-19 symptomatology,\n* Pregnant women,\n* Severe immunosuppression: Neutropenia \\< 0.5 G/L, Chemotherapy \\< 6 months, Bone marrow transplant recipients, HIV with CD4+ lymphocytes \\< 0.4 G/L\n* Impossible to perform bronchoalveolar lavage,\n* Non-socially insured,\n* Refusal to participate in the social study'}, 'identificationModule': {'nctId': 'NCT04359706', 'acronym': 'MICROVID', 'briefTitle': 'Bacterial and Fungal Microbiota of Patients With Severe Viral Pneumonia With COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Bacterial and Fungal Microbiota of Patients With Severe Viral Pneumonia With SARS-CoV2', 'orgStudyIdInfo': {'id': '2020_28'}, 'secondaryIdInfos': [{'id': '2020-A01042-37', 'type': 'OTHER', 'domain': 'ID-RCB number,ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Covid-19 group', 'description': 'Critically ill patients with SARS-CoV-2 infection'}, {'label': 'control group', 'description': 'Historical critically ill patients with no SARS-CoV-2 infection'}]}, 'contactsLocationsModule': {'locations': [{'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Roger Salengro, CHU Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Saad Nseir, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}