PneumoniaCAP'HospiNCT05380193
Serotype Distribution in Hospitalized Adult With Pneumococcal Community Acquired Pneumonia in France
An observational study of Pneumonia and Pneumococcal Infections, run by Institut National de la Santé Et de la Recherche Médicale, France at 5 sites in France.
Trial summary
CAP'Hospi is an observational, multicentric study in France which primary objective is to describe the proportion of Community Acquired Pneumonia due to serotypes included in PCV20 among adults hospitalized for CAP Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Pneumococcal Infections, Community-acquired Pneumonia
- How many people
- 1,017 participants
- Where
- 5 sitesFrance
- Study dates
- 9 May 2022to 6 Feb 2025
- 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: All adults hospitalized more than 24h for Community Acquired Pneumonia
Who may be able to join
- Adults 18 years of age or older
- Admission to hospital for at least 24 hours
- Suspicion of community-acquired pneumonia at admission defined as the association of: Radiologic findings consistent with pneumonia (eg, pleural effusion, increased pulmonary density due to infection and/or alveolar infiltrates [multilobar, lobar, or segmental] containing air bronchograms), AND The presence of ≥2 of the following signs or symptoms: Fever (oral temperature >38°C or tympanic temperature >38.5°C) in the 24 hours preceding admission; Hypothermia (<35.5°C measured by a healthcare provider) in the 24 hours preceding admission ; Chills or rigors ; Pleuritic chest pain ; New or worsening cough ; Sputum production ; Dyspnea (shortness of breath); Tachypnea (respiratory rate >20/min) ; Malaise ; Abnormal auscultatory findings suggestive of pneumonia (rales or evidence of pulmonary consolidation)
- Written informed consent from the patient
Who cannot join
- Suspicion of tuberculosis
- Individuals placed under judicial protection
- Individuals who refuse the transfer of biological samples to the USA
- Patient developing signs and symptoms of pneumonia after having been hospitalized for 48 hours or more
- Pregnancy
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Hopital de la Croix Rousse, Hospices Civils de Lyon
Lyon, 69004
Hôpital Cochin
Paris, 75014
Hôpital Bichat
Paris, 75018
CHU Rennes
Rennes, Brittany Region, 35000
CHU de Saint-Etienne
Saint-Etienne, 42055
About this study
CAP'Hospi is an observational, multicentric study in France which primary objective is to describe the proportion of Community Acquired Pneumonia due to serotypes included in PCV20 among adults hospitalized for CAP
- Keywords
- France, Vaccine, pneumococcal infections
- Medical subject headings
- Pneumonia, Pneumococcal Infections, Community-Acquired Pneumonia
What is being measured
The primary outcome is the main question the study is designed to answer.
proportions of S. pneumoniae serotypes included in PCV20
The proportion will be determined by UAD assay and/or culture from any sites overall and by age and risk group among adults hospitalized with CAP
Measured: 2 years
Secondary outcomes (6)
proportion of serotypes of S. pneumoniae by group
Among adults hospitalized for all-cause CAP or pneumococcal CAP the proportion of serotypes of S. pneumoniae grouped by serotypes included into pneumococcal vaccines and individual serotypes, by age and risk group
Measured: 2 years
Patients hospital trajectories
The proportion of patients who died from any cause, the proportion of patients requiring mechanical ventilation within the first 30 days of hospitalization, the proportion of patients who required transfer to ICU within the first 30 days of hospitalization, the length of ICU-stay, the length of hospital-stay, the proportion of patients who required hospital re-admission
Measured: 2 years
Patients hospital stay by serotype groups
The proportion of patients who died from any cause, the proportion of patients requiring mechanical ventilation within the first 30 days of hospitalization, the proportion of patients who required transfer to ICU within the first 30 days of hospitalization, the length of ICU-stay, the length of hospital-stay, the proportion of patients who required hospital re-admission
Measured: 2 years
Prevalence of different bacterial and viral causes of hospitalized CAP
description of the proportion of bacteria and virus attributable to each patients
Measured: 2 years
The proportion of patients with a severe CAP
transfer to the ICU during hospitalization. Studied factors will include baseline characteristics of patients and pneumococcal and pneumococcal serotype pneumonia etiology
Measured: 2 years
The proportion of patients who required re-hospitalization following hospital discharge
Studied factors will include baseline characteristics of patients and pneumococcal and pneumococcal serotype pneumonia etiology
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start9 May 2022
- Primary completion6 Feb 2025
- Study completion6 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 1,017 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Liem B Luong, MD, Principal investigator, CIC 1417 Cochin-Pasteur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380193
- Sponsor's protocol ID
- C21-24
- Other IDs
- 2021-A03157-34
- Acronym
- CAP'Hospi
- Status last verified
- May 2025
- First submitted
- 7 Mar 2022
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serotype Distribution in Hospitalized Adult With Pneumococcal Community Acquired Pneumonia in France
- ClinicalTrials.gov ID
- NCT05380193
- Acronym / sponsor ID
- CAP'Hospi / C21-24
- Keywords
- France, Vaccine, pneumococcal infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,017 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 9 May 2022 (actual)
- Primary completion
- 6 Feb 2025 (actual)
- Study completion
- 6 Feb 2025 (actual)
- First posted
- 18 May 2022 (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.
CAP'Hospi is an observational, multicentric study in France which primary objective is to describe the proportion of Community Acquired Pneumonia due to serotypes included in PCV20 among adults hospitalized for CAP
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults hospitalized more than 24h for Community Acquired Pneumonia
Key inclusion criteria (4 listed)
- Adults 18 years of age or older
- Admission to hospital for at least 24 hours
- Suspicion of community-acquired pneumonia at admission defined as the association of: Radiologic findings consistent with pneumonia (eg, pleural effusion, increased pulmonary density due to infection and/or alveolar infiltrates [multilobar, lobar, or segmental] containing air bronchograms), AND The presence of ≥2 of the following signs or symptoms: Fever (oral temperature >38°C or tympanic temperature >38.5°C) in the 24 hours preceding admission; Hypothermia (<35.5°C measured by a healthcare provider) in the 24 hours preceding admission ; Chills or rigors ; Pleuritic chest pain ; New or worsening cough ; Sputum production ; Dyspnea (shortness of breath); Tachypnea (respiratory rate >20/min) ; Malaise ; Abnormal auscultatory findings suggestive of pneumonia (rales or evidence of pulmonary consolidation)
- Written informed consent from the patient
Key exclusion criteria (5 listed)
- Suspicion of tuberculosis
- Individuals placed under judicial protection
- Individuals who refuse the transfer of biological samples to the USA
- Patient developing signs and symptoms of pneumonia after having been hospitalized for 48 hours or more
- Pregnancy
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
proportions of S. pneumoniae serotypes included in PCV20
Time frame: 2 years
The proportion will be determined by UAD assay and/or culture from any sites overall and by age and risk group among adults hospitalized with CAP
6 secondary outcomes
proportion of serotypes of S. pneumoniae by group
Time frame: 2 years
Patients hospital trajectories
Time frame: 2 years
Patients hospital stay by serotype groups
Time frame: 2 years
Prevalence of different bacterial and viral causes of hospitalized CAP
Time frame: 2 years
The proportion of patients with a severe CAP
Time frame: 2 years
The proportion of patients who required re-hospitalization following hospital discharge
Time frame: 2 years
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 15 May 2025.
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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.
Liem B Luong, MD principal investigator
CIC 1417 Cochin-Pasteur
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia and Pneumococcal Infections, run by Institut National de la Santé Et de la Recherche Médicale, France at 5 sites in France.
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 4 inclusion and 5 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 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
proportions of S. pneumoniae serotypes included in PCV20 (time frame: 2 years). 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 15 May 2025.