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

Pneumonia Clinical Trial

— CAP'Hospi  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05380193
• Other study ID #: C21-24
• Secondary ID: 2021-A03157-34
• Status: Recruiting
• Start date: May 9, 2022
• Est. completion date: January 2025

Study information

• Verified date: September 2023
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: Liem B Luong, MD
• Phone: +33 1 58 41 19 11
• Email: liem.luong[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: January 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• Pneumococcal Infections
• Pneumonia

Locations

Country	Name	City	State
France	CHU Rennes	Rennes	Bretagne

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	proportion of serotypes of S. pneumoniae by group	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 years
Secondary	Patients hospital trajectories	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	2 years
Secondary	Patients hospital stay by serotype groups	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	2 years
Secondary	Prevalence of different bacterial and viral causes of hospitalized CAP	description of the proportion of bacteria and virus attributable to each patients	2 years
Secondary	The proportion of patients with a severe CAP	transfer to the ICU during hospitalization. Studied factors will include baseline characteristics of patients and pneumococcal and pneumococcal serotype pneumonia etiology	2 years
Secondary	The proportion of patients who required re-hospitalization following hospital discharge	Studied factors will include baseline characteristics of patients and pneumococcal and pneumococcal serotype pneumonia etiology	2 years