Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2026-02-23 @ 1:53 PM
Study NCT ID:
NCT00308659
Status:
UNKNOWN
Last Update Posted:
2006-03-30
First Post:
2006-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate Two Diagnostic Strategies for the Treatment of Severe Community Acquired Pneumonia (SCAP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-03', 'lastUpdateSubmitDate': '2006-03-28', 'studyFirstSubmitDate': '2006-03-28', 'studyFirstSubmitQcDate': '2006-03-28', 'lastUpdatePostDateStruct': {'date': '2006-03-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-30', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Community Aquired Pneumonia']}, 'descriptionModule': {'briefSummary': "Main hypothesis: microbiological diagnossis off severe community acquired pneumonia can be performed by non invasive or semi invasive microbiological tools, semi invasive tools including protected distal bronchial samplings by the mean of Fiber optic bronchoscopy (FOB). A microbiological diagnosis could improve antibiotic therapy efficacy and improve patient's outcome.\n\nThese Two strategies have never been prospectivally evauated.\n\n* Aim of the study: To evaluate 2 diagnostic strategies: non invasive or semi invasive including protected distal bronchial samplings by the mean of Fiber optic bronchoscopy (FOB)for the care of patients admitted in intensive care for severe community acquired pneumonia and receiving an empirical antibiotic therapy as recommanded by 2001 American thoracic guidelines\n* Type of study randomized multicentric controlled open study", 'detailedDescription': '\uf0b7Type of study randomized multicentric controlled open study\n\nNumber of patients: 200 patients (100 patients in each group)admitted in ICU for SCAP\n\n* Number of center : 5\n* Clinical strategies under evaluation :\n* Group A: semi-invasive strategy: FOB within 24 hours after ICU admission\n* Group B: non-invasive strategy: no FOB within 24 hours after ICU admission\n* Evaluation criteria:\n\nMain criteria: Changes in initial empirical antibiotic treatment according to microbiological results obtained in each group.\n\nothers\n\n* FOB related complications\n* Microbiological results\n* Type of antibiotic treatment modifications\n* ICU outcome and outcome at day 28\n* Duration of antibiotic therapy and nimber of days without antibiotics at day 28 after inclusion'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nNew radiological infiltrate SCAP clinical diagnosis admitted in ICU Admitted in hospital for less than 24 hours Aged 18 or older Signed informed consent\n\nExclusion Criteria:\n\nPregnancy Muribond patients Previuos hospitalisation within One month Neutropenia None HIV status'}, 'identificationModule': {'nctId': 'NCT00308659', 'briefTitle': 'Study to Evaluate Two Diagnostic Strategies for the Treatment of Severe Community Acquired Pneumonia (SCAP)', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Diagnostic Strategy Evaluation Study of Two Diagnostic Strategies for the Treatment of SCAP : Noninvasive Strategy and Semiinvasive Strategy Including FOB Distal Samplings', 'orgStudyIdInfo': {'id': 'SCAP FOB'}, 'secondaryIdInfos': [{'id': 'CNMR grant, cardiff'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'FOB protected distal microbiological samplings', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75004', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Rabbat antoine, MD', 'role': 'CONTACT', 'email': 'antoine.rabbat@htd.aphp.fr', 'phone': '+33142348637'}, {'name': 'Rabbat antoine, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hotel dieu', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'HERER BERTRAND, MD', 'role': 'CONTACT', 'email': 'formation-aducation@cardif.asso.fr', 'phone': '+33141878801'}], 'overallOfficials': [{'name': 'RABBAT Antoine, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'APHP'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}}}}