NCT07416266

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230,066

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 10, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

10 years

First QC Date

February 10, 2026

Last Update Submit

February 10, 2026

Conditions

Keywords

Primary CareAntimicrobial StewardshipElectronic Health Records

Outcome Measures

Primary Outcomes (1)

  • Participant Characteristics at Index LRTI Episode

    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 Outcomes (5)

  • 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

  • 30-Day LRTI-Related Reconsultation Rate

    30 days

  • 30-Day Severe Complication Rate After LRTI

    30 days

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients (≥18 years) with a recorded episode of community-acquired lower respiratory tract infection (LRTI) in French primary care between January 1, 2015 and December 31, 2024, identified from anonymized electronic health records in the THIN France database. Patients were required to have at least 12 months of prior medical history before the index episode.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Community-Acquired PneumoniaBronchitisInfluenza, Human

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract DiseasesBronchial DiseasesLung Diseases, ObstructiveLung DiseasesOrthomyxoviridae InfectionsRNA Virus InfectionsVirus Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2026

First Posted

February 18, 2026

Study Start

January 1, 2015

Primary Completion

December 31, 2024

Study Completion

January 9, 2026

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual participant data come from an anonymized database with legal and contractual restrictions.