Immunocompromised Patients and Non-immunosuppressed Patients at Risk With an Indication for Pneumococcal Vaccination Clinical Trial
— SAUVACOfficial title:
Evaluation of Pneumococcal Vaccine Coverage
| NCT number | NCT03597269 |
| Other study ID # | SAUVAC |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | September 15, 2017 |
| Est. completion date | December 31, 2018 |
| Verified date | February 2019 |
| Source | Groupe Hospitalier Paris Saint Joseph |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | December 31, 2018 |
| Est. primary completion date | January 31, 2018 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Groupe Hospitalier Paris Saint-Joseph | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Groupe Hospitalier Paris Saint Joseph |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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). | Day 1 |