Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 9:54 PM
Study NCT ID:
NCT07416266
Status:
COMPLETED
Last Update Posted:
2026-02-18
First Post:
2026-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lower Respiratory Tract Infections Managed in Primary Care in France
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098968', 'term': 'Community-Acquired Pneumonia'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D017714', 'term': 'Community-Acquired Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 230066}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-01-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-10', 'studyFirstSubmitDate': '2026-02-10', 'studyFirstSubmitQcDate': '2026-02-10', 'lastUpdatePostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participant Characteristics at Index LRTI Episode', 'timeFrame': 'Index consultation', 'description': 'Descriptive summary of participant characteristics at the index lower respiratory tract infection episode, including age, sex, body mass index, smoking status, alcohol use, comorbidities, and vaccination status, overall and by antibiotic exposure group.'}], 'secondaryOutcomes': [{'measure': 'Antibiotic Prescribing Rate', 'timeFrame': 'Index consultation', 'description': 'Proportion of participants with an antibiotic prescription at the index episode, stratified on LRTI type'}, {'measure': 'Type of Antibiotics Prescribed for Antibiotic-treated LRTIs', 'timeFrame': 'Index consultation', 'description': 'Distribution of antibiotic classes prescribed at the index episode.'}, {'measure': 'Duration of Antibiotic Treatment for Antiobiotic-treated LRTIs', 'timeFrame': 'Index consultation', 'description': 'Duration of antibiotic treatment prescribed for the index episode.'}, {'measure': '30-Day LRTI-Related Reconsultation Rate', 'timeFrame': '30 days', 'description': 'Proportion of participants with a follow-up consultation related to LRTI within 30 days.'}, {'measure': '30-Day Severe Complication Rate After LRTI', 'timeFrame': '30 days', 'description': 'Occurrence of Sepsis/septic shock, Pleural effusion, Lung abscess, Acute respiratory distress syndrome (ARDS) within 30 days after the index episode.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Primary Care', 'Antimicrobial Stewardship', 'Electronic Health Records'], 'conditions': ['Lower Respiratory Tract Infections', 'Community Acquired Pneumonia (CAP)', 'Acute Bronchitis', 'Acute Exacerbation Chronic Obstructive Pulmonary Disease', 'Influenza']}, 'descriptionModule': {'briefSummary': 'Primary aim:\n\nTo describe participant characteristics at the time of the index lower respiratory tract infection (LRTI) episode in adults managed in primary care in France, using anonymized electronic health records from routine clinical practice between January 2015 and December 2024.\n\nSecondary aims:\n\nTo describe and quantify patterns of antibiotic prescribing (rate, type, and duration of treatment) and short-term outcomes, including LRTI-related reconsultations and severe complications within 30 days after the index consultation.\n\nThe overall objective is to better characterize real-world management and outcomes of lower respiratory tract infections in primary care and to identify potential areas for improving quality of care and optimizing antibiotic stewardship.', 'detailedDescription': 'Lower respiratory tract infections are a frequent reason for consultation and antibiotic prescribing in primary care. However, nationally representative data describing real-world management in routine practice remain limited in France.\n\nThis nationwide retrospective observational study uses anonymized electronic health records from the THIN® France database, a large primary care data warehouse collecting routinely recorded clinical data from general practitioners. The study includes adults aged 18 years and older with a recorded episode of community-acquired lower respiratory tract infection between January 2015 and December 2024.\n\nEach participant contributes a single index episode and is followed for 30 days to assess short-term outcomes. The study period allows the evaluation of management practices over a 10-year timeframe in routine ambulatory care.\n\nThe main objective is to describe patients characteristics and real-world management of lower respiratory tract infections in primary care, with a focus on patterns of care, treatment strategies, and short-term outcomes. This study is based exclusively on previously collected anonymized data and does not involve any intervention or change in patient care.\n\nBy providing a large-scale overview of routine practice, the study aims to improve understanding of current management approaches and identify potential areas for optimizing antibiotic use in primary care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients (≥18 years) with a recorded episode of community-acquired lower respiratory tract infection (LRTI) in French primary care between January 1, 2015 and December 31, 2024, identified from anonymized electronic health records in the THIN France database. Patients were required to have at least 12 months of prior medical history before the index episode.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* Recorded diagnosis of community-acquired lower respiratory tract infection in primary care between Jan 1, 2015 and Dec 31, 2024\n* At least 12 months of medical history available before the index consultation\n\nExclusion Criteria:\n\n* Age \\<18 years\n* Less than 12 months of medical data before index date'}, 'identificationModule': {'nctId': 'NCT07416266', 'briefTitle': 'Lower Respiratory Tract Infections Managed in Primary Care in France', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital Raymond Poincaré'}, 'officialTitle': 'Lower Respiratory Tract Infections Managed in Primary Care: A 10-year Nationwide Real-World Data Warehouse Study', 'orgStudyIdInfo': {'id': 'LRTI-20152024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Antibiotic-Treated LRTI', 'description': 'Adults with a recorded community-acquired lower respiratory tract infection (LRTI) in primary care in France between January 2015 and December 2024 whose index episode was associated with an antibiotic prescription during routine care. No intervention was assigned by the study.'}, {'label': 'Non-Antibiotic-Treated LRTI', 'description': 'Adults with a recorded community-acquired lower respiratory tract infection (LRTI) in primary care in France between January 2015 and December 2024 whose index episode was not associated with an antibiotic prescription during routine care. No intervention was assigned by the study.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data come from an anonymized database with legal and contractual restrictions.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital Raymond Poincaré', 'class': 'OTHER'}, 'collaborators': [{'name': 'Versailles Saint-Quentin-en-Yvelines University', 'class': 'OTHER'}, {'name': 'University of Lausanne Hospitals', 'class': 'OTHER'}, {'name': 'Clinityx by Gers Data', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}