Lower Respiratory Tract InfectionsNCT07416266
Lower Respiratory Tract Infections Managed in Primary Care in France
An observational study of Lower Respiratory Tract Infections and Community Acquired Pneumonia (CAP), run by Hôpital Raymond Poincaré.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Respiratory Tract Infections, Community Acquired Pneumonia (CAP), Acute Bronchitis
- How many people
- 230,066 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 9 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Age <18 years
- Less than 12 months of medical data before index date
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Lower Respiratory Tract Infections, Community Acquired Pneumonia (CAP), Acute Bronchitis, Acute Exacerbation Chronic Obstructive Pulmonary Disease, Influenza
- Keywords
- Primary Care, Antimicrobial Stewardship, Electronic Health Records
- Medical subject headings
- Community-Acquired Pneumonia, Bronchitis, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Index consultation
Secondary outcomes (5)
Antibiotic Prescribing Rate
Proportion of participants with an antibiotic prescription at the index episode, stratified on LRTI type
Measured: Index consultation
Type of Antibiotics Prescribed for Antibiotic-treated LRTIs
Distribution of antibiotic classes prescribed at the index episode.
Measured: Index consultation
Duration of Antibiotic Treatment for Antiobiotic-treated LRTIs
Duration of antibiotic treatment prescribed for the index episode.
Measured: Index consultation
30-Day LRTI-Related Reconsultation Rate
Proportion of participants with a follow-up consultation related to LRTI within 30 days.
Measured: 30 days
30-Day Severe Complication Rate After LRTI
Occurrence of Sepsis/septic shock, Pleural effusion, Lung abscess, Acute respiratory distress syndrome (ARDS) within 30 days after the index episode.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start1 Jan 2015
- Primary completion31 Dec 2024
- Study completion9 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Respiratory Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 230,066 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Raymond Poincaré
- Sponsor type
- University, hospital or other
- Collaborators
- Versailles Saint-Quentin-en-Yvelines University, University of Lausanne Hospitals, Clinityx by Gers Data
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416266
- Sponsor's protocol ID
- LRTI-20152024
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data come from an anonymized database with legal and contractual restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Respiratory Tract Infections Managed in Primary Care: A 10-year Nationwide Real-World Data Warehouse Study
- ClinicalTrials.gov ID
- NCT07416266
- Acronym / sponsor ID
- LRTI-20152024
- Conditions
- Lower Respiratory Tract Infections, Community Acquired Pneumonia (CAP), Acute Bronchitis, Acute Exacerbation Chronic Obstructive Pulmonary Disease, Influenza
- Keywords
- Primary Care, Antimicrobial Stewardship, Electronic Health Records
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230,066 participants (actual)
- Lead sponsor
- Hôpital Raymond PoincaréUniversity, hospital or other
- Collaborators
- Versailles Saint-Quentin-en-Yvelines University, University of Lausanne Hospitals, Clinityx by Gers Data
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 9 Jan 2026 (actual)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Age <18 years
- Less than 12 months of medical data before index date
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Antibiotic Prescribing Rate
Time frame: Index consultation
Type of Antibiotics Prescribed for Antibiotic-treated LRTIs
Time frame: Index consultation
Duration of Antibiotic Treatment for Antiobiotic-treated LRTIs
Time frame: Index consultation
30-Day LRTI-Related Reconsultation Rate
Time frame: 30 days
30-Day Severe Complication Rate After LRTI
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data come from an anonymized database with legal and contractual restrictions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Respiratory Tract Infections and Community Acquired Pneumonia (CAP), run by Hôpital Raymond Poincaré.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Characteristics at Index LRTI Episode (time frame: Index consultation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.