Evaluation of Pneumococcal Vaccine Coverage (SAUVAC)

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 Overview

• Status: Completed
• Conditions: Immunocompromised Patients and Non-immunosuppressed Patients at Risk With an Indication for Pneumococcal Vaccination

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Groupe Hospitalier Paris Saint-Joseph

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Paris Saint Joseph
• Investigators: Principal Investigator: Cécile P CAISSO, MD, Groupe hospitalier Paris saint Joseph

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2017
• Primary Completion (Actual): January 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: July 13, 2018
• First Submitted That Met QC Criteria: July 23, 2018
• First Posted (Actual): July 24, 2018

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 12, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: SAUVAC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No