Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05380193




Registration number
NCT05380193
Ethics application status
Date submitted
7/03/2022
Date registered
18/05/2022
Date last updated
1/10/2024

Titles & IDs
Public title
Serotype Distribution in Hospitalized Adult with Pneumococcal Community Acquired Pneumonia in France
Scientific title
Serotype Distribution in Hospitalized Adult with Pneumococcal Community Acquired Pneumonia in France
Secondary ID [1] 0 0
2021-A03157-34
Secondary ID [2] 0 0
C21-24
Universal Trial Number (UTN)
Trial acronym
CAP'Hospi
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pneumonia 0 0
Pneumococcal Infections 0 0
Community-acquired Pneumonia 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
proportions of S. pneumoniae serotypes included in PCV20
Timepoint [1] 0 0
2 years
Secondary outcome [1] 0 0
proportion of serotypes of S. pneumoniae by group
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
Patients hospital trajectories
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Patients hospital stay by serotype groups
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
Prevalence of different bacterial and viral causes of hospitalized CAP
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
The proportion of patients with a severe CAP
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
The proportion of patients who required re-hospitalization following hospital discharge
Timepoint [6] 0 0
2 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2025
Actual
Sample size
Target
2000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Bretagne

Funding & Sponsors
Primary sponsor type
Government body
Name
Institut National de la Santé Et de la Recherche Médicale, France
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/study/NCT05380193
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Liem B Luong, MD
Address 0 0
CIC 1417 Cochin-Pasteur
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05380193