Surveillance of Invasive Pneumococcal Infections in Adults (Excluding Meningitis)

NCT03983616 | Unknown

• 1 other identifier: SIIP
• Study Type: observational
• Target: 1,560
• Locations: 1 country
• Sites: 1

Brief Summary

Given the frequency and severity of invasive pneumococcal infections and questions about the place of VPC-13 in the prevention of pneumococcal infections in adults based on the presence of risk factors, current laboratory surveillance should be supplemented with data on the clinical features of adult invasive pneumococcal infections (IPI) cases. In particular it is necessary to collect for these cases, the clinical forms, the severity and the existence of risk factors and to make the link between these characteristics and those strains of pneumococci responsible for the IPI in particular, their serotype. The follow-up of the evolution of the cases according to the presence of risk factors, their clinical form and their serotype coverage (vaccine strain or not) must to guide recommendations for adult VPC-13 and to monitor the effects of VPC-13 vaccination recommendations. These effects are indirect, linked to the effect of vaccination of children with VPC-13 since 2010, which modifies the serotypes responsible for infections in vaccinated and unvaccinated patients, and the direct effects of possible use of the conjugate vaccine in adults (according to the recommendations that will be given by the Vaccination Technical Committee of the High Council of Public Health). The project is based on the existing network of 23 Regional Pneumococcal Observatories (ORP) located in metropolitan France and the network of infectious diseases by completing the microbiological collection of strains of pneumococci isolated from invasive infections in adults by a clinical collection in hospitals or voluntary clinics where the laboratory participates in the ORP. Given the establishment in 2012 of an adult bacterial meningitis observatory, to which the ORP are associated, this project does not include the surveillance of pneumococcal meningitis in adults.

Conditions

Pneumococcal Infections

Keywords

Pneumococcal Infections

Outcome Measures

Primary Outcomes (1)

• Frequency of invasive pneumococcal infections

  identify the frequency of invasive pneumococcal infections in function of the presence of risk factors

  Day 0

Secondary Outcomes (2)

• Weight of invasive pneumococcal infections

  Day 0

• Number of Invasive Pneumococcal Infections in Adults

  Day 0

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adults 18 years of age or older hospitalized for invasive pneumococcal disease in participating institutions.

You may qualify if:

• years old patients or older hospitalized with invasive pneumococcal infection confirmed by isolation of a strain from a usually sterile site: blood or pleural fluid

You may not qualify if:

• Pneumococcal meningitis identified by pneumococcal isolation or pneumococcal positive polymerase chain reaction (PCR) in cerebrospinal fluid

Sponsors & Collaborators

• University Hospital, Limoges: lead
• INVS: collaborator
• ORP: collaborator
• CNRP: collaborator
• SPILF: collaborator

Study Sites (1)

Service de Virologie

Limoges, France

RECRUITING

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Central Study Contacts

Marie-Cécile PLOY, MD

CONTACT

marie-cecile.ploy@unilim.fr

Study Design

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

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 12, 2019
• Study Start: April 1, 2014
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: June 12, 2019

Record last verified: 2019-06

Locations

FR (1)