Surveillance of Invasive Pneumococcal Infections in Adults (Excluding Meningitis)

Pneumococcal Infections Clinical Trial

— SIIP  

Official title:

Surveillance of Invasive Pneumococcal Infections in Adults (Excluding Meningitis)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03983616
• Other study ID #: SIIP
• Status: Recruiting
• Start date: April 2014
• Est. completion date: April 2020

Study information

• Verified date: June 2019
• Source: University Hospital, Limoges
• Contact: Marie-Cécile PLOY, MD
• Email: marie-cecile.ploy[@]unilim.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1560
• Est. completion date: April 2020
• Est. primary completion date: April 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Meningitis
• Pneumococcal Infections

Locations

Country	Name	City	State
France	Service de Virologie	Limoges

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Limoges	CNRP, INVS, ORP, SPILF

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of invasive pneumococcal infections	identify the frequency of invasive pneumococcal infections in function of the presence of risk factors	Day 0
Secondary	Weight of invasive pneumococcal infections	measure the weight of invasive pneumococcal infections based on the presence of risk factors and immunization or not	Day 0
Secondary	Number of Invasive Pneumococcal Infections in Adults	monitor the epidemiology of Invasive Pneumococcal Infections in Adults according to strategies for the use of VPC-13 and VPS-23 vaccines in children and adults	Day 0