Condition or disease |
---|
Pneumococcal Infections |
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 |
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Contact: Marie-Cécile PLOY, MD | marie-cecile.ploy@unilim.fr |
France | |
Service de Virologie | Recruiting |
Limoges, France | |
Contact: Marie Cécile PLOY, MD marie-cecile.ploy@unilim.fr | |
Principal Investigator: Marie PLOY, MD |
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 |
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 |
|
||
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 |
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:
Exclusion Criteria:
|
||
Sex/Gender |
|
||
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 |
|
||
Investigators | Not Provided | ||
PRS Account | University Hospital, Limoges | ||
Verification Date | June 2019 |