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OpenTrials
Completed

NCT Number: NCT03983616

Surveillance of Invasive Pneumococcal Infections in Adults (Excluding Meningitis)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Virologie

Limoges, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Frequency of invasive pneumococcal infections

    Time frame: Day 0

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

Secondary outcomes

  1. Weight of invasive pneumococcal infections

    Time frame: Day 0

    measure the weight of invasive pneumococcal infections based on the presence of risk factors and immunization or not

  2. Number of Invasive Pneumococcal Infections in Adults

    Time frame: Day 0

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Collaborators

  • CNRP
  • INVS
  • ORP
  • SPILF

Registry information

Acronym: SIIP

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Jun 12, 2019
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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