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Completed

NCT Number: NCT05380193

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

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

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Key information

Conditions

Pneumonia Bacterial Infections Bacterial Infections and Mycoses Community-Acquired Infections Community-Acquired Pneumonia Gram-Positive Bacterial Infections Infections Lung Diseases Pneumococcal Infections Respiratory Tract Diseases Respiratory Tract Infections Streptococcal Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Rennes, Rennes, Brittany Region, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. proportion of serotypes of S. pneumoniae by group

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 2 years

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

  5. The proportion of patients with a severe CAP

    Time frame: 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

    Time frame: 2 years

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

Sponsors and collaborators

Lead sponsor

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

Other Gov

Registry information

Acronym: CAP'Hospi

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 18, 2022
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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