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出境医 / 临床实验 / Surveillance of Invasive Pneumococcal Infections in Adults (Excluding Meningitis) (SIIP)

Surveillance of Invasive Pneumococcal Infections in Adults (Excluding Meningitis) (SIIP)

Study Description
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.

Condition or disease
Pneumococcal Infections

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 1560 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Surveillance of Invasive Pneumococcal Infections in Adults (Excluding Meningitis)
Actual Study Start Date : April 2014
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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
Contacts and Locations

Contacts
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Contact: Marie-Cécile PLOY, MD marie-cecile.ploy@unilim.fr

Locations
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France
Service de Virologie Recruiting
Limoges, France
Contact: Marie Cécile PLOY, MD       marie-cecile.ploy@unilim.fr   
Principal Investigator: Marie PLOY, MD         
Sponsors and Collaborators
University Hospital, Limoges
INVS
ORP
CNRP
SPILF
Tracking Information
First Submitted Date June 6, 2019
First Posted Date June 12, 2019
Last Update Posted Date June 12, 2019
Actual Study Start Date April 2014
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 11, 2019)
Frequency of invasive pneumococcal infections [ Time Frame: Day 0 ]
identify the frequency of invasive pneumococcal infections in function of the presence of risk factors
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 11, 2019)
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Surveillance of Invasive Pneumococcal Infections in Adults (Excluding Meningitis)
Official Title Surveillance of Invasive Pneumococcal Infections in Adults (Excluding Meningitis)
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Pneumococcal Infections
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 11, 2019)
1560
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03983616
Other Study ID Numbers SIIP
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Limoges
Study Sponsor University Hospital, Limoges
Collaborators
  • INVS
  • ORP
  • CNRP
  • SPILF
Investigators Not Provided
PRS Account University Hospital, Limoges
Verification Date June 2019