Clinical trial NCT05380193: Serotype Distribution in Hospitalized Adult With Pneumococcal Community Acquired Pneumonia in France
Official title: Serotype Distribution in Hospitalized Adult With Pneumococcal Community Acquired Pneumonia in France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia
Pneumococcal Infections
Community-acquired Pneumonia
Keywords: France
Vaccine
pneumococcal infections
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2022-05-18
Enrollment: 1017
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adults hospitalized more than 24h for Community Acquired Pneumonia

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


Eligibility criteria: 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

Primary outcomes:
measure: proportions of S. pneumoniae serotypes included in PCV20
timeFrame: 2 years
Secondary outcomes:
measure: proportion of serotypes of S. pneumoniae by group
timeFrame: 2 years
measure: Patients hospital trajectories
timeFrame: 2 years
measure: Patients hospital stay by serotype groups
timeFrame: 2 years
measure: Prevalence of different bacterial and viral causes of hospitalized CAP
timeFrame: 2 years
measure: The proportion of patients with a severe CAP
timeFrame: 2 years
measure: The proportion of patients who required re-hospitalization following hospital discharge
timeFrame: 2 years
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU Rennes
state: Bretagne
city: Lyon
country: France
facility: Hopital de la Croix Rousse, Hospices Civils de Lyon
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Hôpital Bichat
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CIC 1417 Cochin-Pasteur
name: Liem B Luong, MD
role: PRINCIPAL_INVESTIGATOR
References: