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临床试验/NCT07416266
NCT07416266已完成不适用

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

Hôpital Raymond Poincaré0 个研究点目标入组 230,066 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
230,066
主要终点
Participant Characteristics at Index LRTI Episode

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Age <18 years
  • Less than 12 months of medical data before index date

研究组 & 干预措施

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.

结局指标

主要结局

Participant Characteristics at Index LRTI Episode

时间窗: 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.

次要结局

  • 30-Day LRTI-Related Reconsultation Rate(30 days)
  • 30-Day Severe Complication Rate After LRTI(30 days)
  • Antibiotic Prescribing Rate(Index consultation)
  • Type of Antibiotics Prescribed for Antibiotic-treated LRTIs(Index consultation)
  • Duration of Antibiotic Treatment for Antiobiotic-treated LRTIs(Index consultation)

研究者

发起方
Hôpital Raymond Poincaré
申办方类型
Other
责任方
Sponsor

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