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Prevention of Pneumococcal Infections: Impact Collaborative Medico-pharmaceutical Care Structured to Improve Vaccination Coverage of Patients at Risk. (OPTIVACC)

C

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Conditions

Streptococcus Pneumoniae Infection

Treatments

Other: Structured medico-pharmaceutical collaboration

Study type

Interventional

Funder types

Other

Identifiers

NCT05060146
PHRC-I/2019/FD-01
2020-A01581-38 (Other Identifier)

Details and patient eligibility

About

In France, Streptococcus pneumoniae is the leading agent bacterial involved in community lung disease and meningitis. The frequency of these infections and their mortality increase significantly in those at risk such as patients with certain chronic diseases, immunocompromised or on immunosuppressive therapy. This population, despite regular monitoring, has a limited pneumococcal vaccine coverage of around 20%. By carrying out a reconciliation of treatments upon admission to hospital, the clinical pharmacist can detect those without up to date pneumococcal vaccination status. The goal of this management is to make the patient aware of the need for vaccination and organization upon return home. Thus, this limited pneumococcal vaccination coverage would benefit from intervention by regional clinical pharmacy activities. The study investigators want to study the impact of a structured medico-pharmaceutical collaboration on pneumococcal vaccination of patients with risk on discharge from hospital. The investigators hypothesize that this collaboration in patients at risk of infection with pneumococcus could significantly increase their anti-pneumococcal vaccination coverage

Enrollment

646 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • The patient must have given their free and informed oral consent
  • The patient must be a member or beneficiary of a health insurance plan
  • The patient is admitted to full hospitalization in a surgical or medical department.
  • The patient will benefit from a reconciliation of drug treatments.
  • The patient is considered at risk of pneumococcal infection according to the recommendations of March 2017 of the High Council of Public Health (HCSP)
  • Pneumococcal vaccination is not up to date according to the HCSP 2017 recommendations.

Exclusion criteria

  • The subject is participating in a category 1 interventional study
  • The patient has participated in a category 1 trial within the previous 3 months or is in a period of exclusion determined by a previous study
  • It is impossible to give the subject informed information
  • The patient is under safeguard of justice or state guardianship
  • The patient is not in a fit state to express consent
  • The patient is pregnant, parturient or breast feeding

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

646 participants in 2 patient groups

Standard care
No Intervention group
Structured medico-pharmaceutical collaboration
Experimental group
Treatment:
Other: Structured medico-pharmaceutical collaboration

Trial contacts and locations

9

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Central trial contact

Florent Dubois

Data sourced from clinicaltrials.gov

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