Immunocompromised Patients and Non-immunosuppressed Patients at Risk With an Indication for Pneumococcal VaccinationSAUVACNCT03597269
Evaluation of Pneumococcal Vaccine Coverage
An observational study of Immunocompromised Patients and Non-immunosuppressed Patients at Risk With an Indication for Pneumococcal Vaccination, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Pneumococcal infections are frequent and serious. Streptococcus pneumoniae is the leading cause of community-acquired pneumonia in adults. In metropolitan France, there are 6000 to 7000 bacteremic pneumococcal infections each year, with a mortality rate of 10 to 30% in adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunocompromised Patients and Non-immunosuppressed Patients at Risk With an Indication for Pneumococcal Vaccination
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2017to 31 Dec 2018
- 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 population of the study corresponds to the patients who consulted in an emergency service in Paris during 3 months to determine the anti-pneumococcal vaccination coverage in adults at the scale of a Paris emergency service.
Who may be able to join
- patient over the age of 18
- Patient without cognitive impairment
- Follow-up at the time of inclusion by a physician
- Patient with one or more indications for an anti-pneumococcal vaccination according to the 2017 vaccine recommendations
- Non-immunocompromised patients at risk, with underlying disease predisposing to the occurrence of invasive pneumococcal disease
Who cannot join
- Patient's opposition to participate
- Patients with the following contraindications to pneumococcal vaccination: severe acute infection in progress, allergy to one of the components vaccin
- Patient deprived of liberty
- Patient under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Pneumococcal infections are frequent and serious. Streptococcus pneumoniae is the leading cause of community-acquired pneumonia in adults. In metropolitan France, there are 6000 to 7000 bacteremic pneumococcal infections each year, with a mortality rate of 10 to 30% in adults.
To fight against these bacterial infections, vaccines have been developed. At a time when antibiotic savings and the fight against antimicrobial resistance are major public health issues, vaccination is a first choice option to slow the development of pneumococcal resistance. Thus, after these different actions, the proportions of pneumococci with decreased susceptibility to penicillin G fell from 53 to 22%.
Read more
While there is a significant decrease in invasive pneumococcal disease in children since the use of conjugate vaccines (vaccination of up to 94% of children), the rate of invasive Pneumococcal disease in adults has decreased less significantly.
In March 2017, the High Council of Public Health (HCSP) proposed the vaccination of all non-immunocompromised adults at risk and immunocompromised patients.
Awareness-raising among vaccinating physicians seems essential, especially in recent years when the value of vaccination is threatened by speculation about its efficacy and toxicity. However, the investigators know that vaccination aims not only to protect the individual, but also the population, especially children and the elderly and the fragile people.
Thus, in the context of pneumococcal vaccination, identifying one or more profiles of patients at risk in the absence of vaccination could be particularly beneficial. Indeed, if the physician knows about the population at risk of not being vaccinated, it will be better able to identify patients at risk of not being protected against pneumococcus.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Pneumococcal Vaccine Coverage in Adults with Pneumococcal Vaccine Indication
The primary outcome measure is to evaluate the patient's Immunization status for mandatory vaccinations, his pneumococcal vaccination status and how it was determined (the patient knew it, the presence of a vaccination card, attending physician, indeterminate status).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start15 Sep 2017
- Primary completion31 Jan 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunocompromised Patients and Non-immunosuppressed Patients at Risk With an Indication for Pneumococcal VaccinationStudies of the same condition, open and under way.
- 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cécile P CAISSO, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03597269
- Sponsor's protocol ID
- SAUVAC
- Acronym
- SAUVAC
- Status last verified
- Feb 2019
- First submitted
- 13 Jul 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pneumococcal Vaccine Coverage
- ClinicalTrials.gov ID
- NCT03597269
- Acronym / sponsor ID
- SAUVAC / SAUVAC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 24 Jul 2018 (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.
Pneumococcal infections are frequent and serious. Streptococcus pneumoniae is the leading cause of community-acquired pneumonia in adults. In metropolitan France, there are 6000 to 7000 bacteremic pneumococcal infections each year, with a mortality rate of 10 to 30% in adults.
To fight against these bacterial infections, vaccines have been developed. At a time when antibiotic savings and the fight against antimicrobial resistance are major public health issues, vaccination is a first choice option to slow the development of pneumococcal resistance. Thus, after these different actions, the proportions of pneumococci with decreased susceptibility to penicillin G fell from 53 to 22%.
While there is a significant decrease in invasive pneumococcal disease in children since the use of conjugate vaccines (vaccination of up to 94% of children), the rate of invasive Pneumococcal disease in adults has decreased less significantly.
In March 2017, the High Council of Public Health (HCSP) proposed the vaccination of all non-immunocompromised adults at risk and immunocompromised patients.
Awareness-raising among vaccinating physicians seems essential, especially in recent years when the value of vaccination is threatened by speculation about its efficacy and toxicity. However, the investigators know that vaccination aims not only to protect the individual, but also the population, especially children and the elderly and the fragile people.
Thus, in the context of pneumococcal vaccination, identifying one or more profiles of patients at risk in the absence of vaccination could be particularly beneficial. Indeed, if the physician knows about the population at risk of not being vaccinated, it will be better able to identify patients at risk of not being protected against pneumococcus.
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 population of the study corresponds to the patients who consulted in an emergency service in Paris during 3 months to determine the anti-pneumococcal vaccination coverage in adults at the scale of a Paris emergency service.
Key inclusion criteria (5 listed)
- patient over the age of 18
- Patient without cognitive impairment
- Follow-up at the time of inclusion by a physician
- Patient with one or more indications for an anti-pneumococcal vaccination according to the 2017 vaccine recommendations
- Non-immunocompromised patients at risk, with underlying disease predisposing to the occurrence of invasive pneumococcal disease
Key exclusion criteria (4 listed)
- Patient's opposition to participate
- Patients with the following contraindications to pneumococcal vaccination: severe acute infection in progress, allergy to one of the components vaccin
- Patient deprived of liberty
- Patient under guardianship
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
Evaluation of Pneumococcal Vaccine Coverage in Adults with Pneumococcal Vaccine Indication
Time frame: Day 1
The primary outcome measure is to evaluate the patient's Immunization status for mandatory vaccinations, his pneumococcal vaccination status and how it was determined (the patient knew it, the presence of a vaccination card, attending physician, indeterminate status).
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 15 Feb 2019.
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.
Cécile P CAISSO, MD principal investigator
Fondation Hôpital Saint-Joseph
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 Immunocompromised Patients and Non-immunosuppressed Patients at Risk With an Indication for Pneumococcal Vaccination, run by Fondation Hôpital Saint-Joseph 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 5 inclusion and 4 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 15 Feb 2019. 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?
Evaluation of Pneumococcal Vaccine Coverage in Adults with Pneumococcal Vaccine Indication (time frame: Day 1). 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 15 Feb 2019.