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

NCT05380193 | Completed

• 2 other identifiers: C21-242021-A03157-34
• Study Type: observational
• Target: 1,017
• Locations: 1 country
• Sites: 5

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

Conditions

Pneumonia; Pneumococcal Infections; Community-acquired Pneumonia

Keywords

France; Vaccine; pneumococcal infections

Outcome Measures

Primary Outcomes (1)

• 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

  2 years

Secondary Outcomes (6)

• proportion of serotypes of S. pneumoniae by group

  2 years

• Patients hospital trajectories

  2 years

• Patients hospital stay by serotype groups

  2 years

• Prevalence of different bacterial and viral causes of hospitalized CAP

  2 years

• The proportion of patients with a severe CAP

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All adults hospitalized more than 24h for Community Acquired Pneumonia

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (5)

CHU Rennes

Rennes, Brittany Region, 35000, France

Location

Hopital de la Croix Rousse, Hospices Civils de Lyon

Lyon, 69004, France

Location

Hôpital Cochin

Paris, 75014, France

Location

Hôpital Bichat

Paris, 75018, France

Location

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine samples

MeSH Terms

Conditions

Pneumonia; Pneumococcal Infections; Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

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

Study Officials

• Liem B Luong, MD

  CIC 1417 Cochin-Pasteur

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: May 18, 2022
• Study Start: May 9, 2022
• Primary Completion: February 6, 2025
• Study Completion: February 6, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

FR (5)