Pneumococcal InfectionsSIIPNCT03983616
Surveillance of Invasive Pneumococcal Infections in Adults (Excluding Meningitis)
An observational study of Pneumococcal Infections, run by University Hospital, Limoges at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumococcal Infections
- How many people
- 1,560 participants
- Where
- 1 siteFrance
- Study dates
- 12 Apr 2014to 15 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: The study population consists of adults 18 years of age or older hospitalized for invasive pneumococcal disease in participating institutions.
Who may be able to join
- 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
Who cannot join
- Pneumococcal meningitis identified by pneumococcal isolation or pneumococcal positive polymerase chain reaction (PCR) in cerebrospinal fluid
Trial locations and contacts
1 site in 1 country.
About this study
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
- Medical subject headings
- Pneumococcal Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of invasive pneumococcal infections
identify the frequency of invasive pneumococcal infections in function of the presence of risk factors
Measured: Day 0
Secondary outcomes (2)
Weight of invasive pneumococcal infections
measure the weight of invasive pneumococcal infections based on the presence of risk factors and immunization or not
Measured: Day 0
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
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start12 Apr 2014
- Primary completion15 Jun 2020
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal InfectionsStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Collaborators
- INVS, ORP, CNRP, SPILF
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03983616
- Sponsor's protocol ID
- SIIP
- Acronym
- SIIP
- Status last verified
- Jun 2019
- First submitted
- 6 Jun 2019
- Last updated
- 24 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance of Invasive Pneumococcal Infections in Adults (Excluding Meningitis)
- ClinicalTrials.gov ID
- NCT03983616
- Acronym / sponsor ID
- SIIP / SIIP
- Conditions
- Pneumococcal Infections
- Keywords
- Pneumococcal Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,560 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Collaborators
- INVS, ORP, CNRP, SPILF
- Study start
- 12 Apr 2014 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 12 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adults 18 years of age or older hospitalized for invasive pneumococcal disease in participating institutions.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Pneumococcal meningitis identified by pneumococcal isolation or pneumococcal positive polymerase chain reaction (PCR) in cerebrospinal fluid
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of invasive pneumococcal infections
Time frame: Day 0
identify the frequency of invasive pneumococcal infections in function of the presence of risk factors
2 secondary outcomes
Weight of invasive pneumococcal infections
Time frame: Day 0
Number of Invasive Pneumococcal Infections in Adults
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumococcal Infections, run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of invasive pneumococcal infections (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.