Clinical Trials Directory

Trials / Completed

CompletedNCT07416266

Lower Respiratory Tract Infections Managed in Primary Care in France

Lower Respiratory Tract Infections Managed in Primary Care: A 10-year Nationwide Real-World Data Warehouse Study

Status
Completed
Phase
Study type
Observational
Enrollment
230,066 (actual)
Sponsor
Hôpital Raymond Poincaré · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Primary aim: To 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. Secondary aims: To 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. The 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.

Detailed description

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. This 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. Each 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. The 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. By 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.

Conditions

Timeline

Start date
2015-01-01
Primary completion
2024-12-31
Completion
2026-01-09
First posted
2026-02-18
Last updated
2026-02-18

Source: ClinicalTrials.gov record NCT07416266. Inclusion in this directory is not an endorsement.