CAP'Hospi: Serotype Distribution in Hospitalized Adult With Pneumococcal Community Acquired Pneumonia in France

Sponsor
Institut National de la Santé Et de la Recherche Médicale, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT05380193
Collaborator
(none)
2,000
1
31.8
62.9

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Serotype Distribution in Hospitalized Adult With Pneumococcal Community Acquired Pneumonia in France
    Actual Study Start Date :
    May 9, 2022
    Anticipated Primary Completion Date :
    Sep 1, 2024
    Anticipated Study Completion Date :
    Jan 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. proportions of S. pneumoniae serotypes included in PCV20 [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

    Secondary Outcome Measures

    1. proportion of serotypes of S. pneumoniae by group [2 years]

      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

    2. Patients hospital trajectories [2 years]

      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

    3. Patients hospital stay by serotype groups [2 years]

      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

    4. Prevalence of different bacterial and viral causes of hospitalized CAP [2 years]

      description of the proportion of bacteria and virus attributable to each patients

    5. The proportion of patients with a severe CAP [2 years]

      transfer to the ICU during hospitalization. Studied factors will include baseline characteristics of patients and pneumococcal and pneumococcal serotype pneumonia etiology

    6. The proportion of patients who required re-hospitalization following hospital discharge [2 years]

      Studied factors will include baseline characteristics of patients and pneumococcal and pneumococcal serotype pneumonia etiology

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Rennes Rennes Bretagne France 35000

    Sponsors and Collaborators

    • Institut National de la Santé Et de la Recherche Médicale, France

    Investigators

    • Principal Investigator: Liem B Luong, MD, CIC 1417 Cochin-Pasteur

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Institut National de la Santé Et de la Recherche Médicale, France
    ClinicalTrials.gov Identifier:
    NCT05380193
    Other Study ID Numbers:
    • C21-24
    • 2021-A03157-34
    First Posted:
    May 18, 2022
    Last Update Posted:
    May 18, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 18, 2022