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Completed

NCT Number: NCT07416266

Lower Respiratory Tract Infections Managed in Primary Care in France

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Antibiotic Prescribing Rate

    Time frame: Index consultation

    Proportion of participants with an antibiotic prescription at the index episode, stratified on LRTI type

  2. Type of Antibiotics Prescribed for Antibiotic-treated LRTIs

    Time frame: Index consultation

    Distribution of antibiotic classes prescribed at the index episode.

  3. Duration of Antibiotic Treatment for Antiobiotic-treated LRTIs

    Time frame: Index consultation

    Duration of antibiotic treatment prescribed for the index episode.

  4. 30-Day LRTI-Related Reconsultation Rate

    Time frame: 30 days

    Proportion of participants with a follow-up consultation related to LRTI within 30 days.

  5. 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.

Sponsors and collaborators

Lead sponsor

Hôpital Raymond Poincaré

Other

Collaborators

  • Clinityx by Gers Data
  • University of Lausanne Hospitals
  • Versailles Saint-Quentin-en-Yvelines University

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2024
Study completion
2026
First posted
Feb 18, 2026
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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