- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07416266
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
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.
Study Overview
Status
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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥18 years
- Recorded diagnosis of community-acquired lower respiratory tract infection in primary care between Jan 1, 2015 and Dec 31, 2024
- At least 12 months of medical history available before the index consultation
Exclusion Criteria:
- Age <18 years
- Less than 12 months of medical data before index date
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Antibiotic-Treated LRTI
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.
|
|
Non-Antibiotic-Treated LRTI
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant Characteristics at Index LRTI Episode
Time Frame: Index consultation
|
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.
|
Index consultation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Antibiotic Prescribing Rate
Time Frame: Index consultation
|
Proportion of participants with an antibiotic prescription at the index episode, stratified on LRTI type
|
Index consultation
|
|
Type of Antibiotics Prescribed for Antibiotic-treated LRTIs
Time Frame: Index consultation
|
Distribution of antibiotic classes prescribed at the index episode.
|
Index consultation
|
|
Duration of Antibiotic Treatment for Antiobiotic-treated LRTIs
Time Frame: Index consultation
|
Duration of antibiotic treatment prescribed for the index episode.
|
Index consultation
|
|
30-Day LRTI-Related Reconsultation Rate
Time Frame: 30 days
|
Proportion of participants with a follow-up consultation related to LRTI within 30 days.
|
30 days
|
|
30-Day Severe Complication Rate After LRTI
Time Frame: 30 days
|
Occurrence of Sepsis/septic shock, Pleural effusion, Lung abscess, Acute respiratory distress syndrome (ARDS) within 30 days after the index episode.
|
30 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LRTI-20152024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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