Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
NCT01431326
Adenoviridae Infections, Adenovirus
Anchorage, Alaska, United States
View Trial DetailsNCT Number: NCT07416266
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.
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Notify Me18 year and older
All sexes
Observational
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Index consultation
Proportion of participants with an antibiotic prescription at the index episode, stratified on LRTI type
Time frame: Index consultation
Distribution of antibiotic classes prescribed at the index episode.
Time frame: Index consultation
Duration of antibiotic treatment prescribed for the index episode.
Time frame: 30 days
Proportion of participants with a follow-up consultation related to LRTI within 30 days.
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.
Hôpital Raymond Poincaré
Other
Lower Respiratory Tract Infections Managed in Primary Care: A 10-year Nationwide Real-World Data Warehouse Study
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