SAUVAC: Evaluation of Pneumococcal Vaccine Coverage

Sponsor
Groupe Hospitalier Paris Saint Joseph (Other)
Overall Status
Completed
CT.gov ID
NCT03597269
Collaborator
(none)
80
1
15.5
5.2

Study Details

Study Description

Brief 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.

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

Study Type:
Observational
Actual Enrollment :
80 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of Pneumococcal Vaccine Coverage
Actual Study Start Date :
Sep 15, 2017
Actual Primary Completion Date :
Jan 31, 2018
Actual Study Completion Date :
Dec 31, 2018

Outcome Measures

Primary Outcome Measures

  1. Evaluation of Pneumococcal Vaccine Coverage in Adults with Pneumococcal Vaccine Indication [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Groupe Hospitalier Paris Saint-Joseph Paris France 75014

Sponsors and Collaborators

  • Groupe Hospitalier Paris Saint Joseph

Investigators

  • Principal Investigator: Cécile P CAISSO, MD, Groupe Hospitalier Paris Saint Joseph

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier:
NCT03597269
Other Study ID Numbers:
  • SAUVAC
First Posted:
Jul 24, 2018
Last Update Posted:
Feb 15, 2019
Last Verified:
Feb 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 15, 2019