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Serotype Distribution in Hospitalized Adult With Pneumococcal Community Acquired Pneumonia in France

Serotype Distribution in Hospitalized Adult With Pneumococcal Community Acquired Pneumonia in France

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05380193
Acronym
CAP'Hospi
Enrollment
1017
Registered
2022-05-18
Start date
2022-05-09
Completion date
2025-02-06
Last updated
2025-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Community-acquired Pneumonia, Pneumococcal Infections, Pneumonia

Keywords

France, Vaccine, pneumococcal infections

Brief 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

Interventions

None listed

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Adults 18 years of age or older 2. Admission to hospital for at least 24 hours 3. 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) 4. Written informed consent from the patient

Exclusion criteria

1. Suspicion of tuberculosis 2. Individuals placed under judicial protection 3. Individuals who refuse the transfer of biological samples to the USA 4. Patient developing signs and symptoms of pneumonia after having been hospitalized for 48 hours or more 5. Pregnancy

Design outcomes

Primary

MeasureTime frameDescription
proportions of S. pneumoniae serotypes included in PCV202 yearsThe 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

Secondary

MeasureTime frameDescription
Patients hospital trajectories2 yearsThe 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
Patients hospital stay by serotype groups2 yearsThe 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
proportion of serotypes of S. pneumoniae by group2 yearsAmong 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
The proportion of patients with a severe CAP2 yearstransfer to the ICU during hospitalization. Studied factors will include baseline characteristics of patients and pneumococcal and pneumococcal serotype pneumonia etiology
The proportion of patients who required re-hospitalization following hospital discharge2 yearsStudied factors will include baseline characteristics of patients and pneumococcal and pneumococcal serotype pneumonia etiology
Prevalence of different bacterial and viral causes of hospitalized CAP2 yearsdescription of the proportion of bacteria and virus attributable to each patients

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026