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Completed

NCT Number: NCT05060146

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

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

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Key information

Conditions

Streptococcus Pneumoniae Infection Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Pneumococcal Infections Streptococcal Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Alès Cévennes, Alès, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Structured medico-pharmaceutical collaboration

Other

Reconciliation of drug treatments; Writing of the prescription for discharge from hospital for the pneumococcal vaccine; Pharmaceutical interview at discharge; Drafting of the discharge letter and transmission to the attending physician; Writing of the pharmaceutical discharge letter and transmission to the pharmacist; Pharmaceutical dispensing in the pharmacy; Administration of the vaccine by the attending physician or a nurse at home.

Primary outcomes

  1. Full vaccination coverage (2 doses) between groups

    Time frame: 6 months after discharge

    Yes/No, confirmed by the administrator

Secondary outcomes

  1. Full vaccination coverage (2 doses) between groups, stratified by type of establishment (University hospital vs hospital) and by service (Medicine vs Surgery)

    Time frame: 6 months after discharge

    Yes/No, confirmed by the administrator

  2. Partial vaccination coverage (1st dose only) between groups and stratified by type of establishment (University hospital vs hospital) and by service (Medicine vs Surgery)

    Time frame: 6 months after discharge

    Yes/No, confirmed by the administrator

  3. Record of both vaccines being dispensed by the pharmacy between groups and stratified by type of establishment (University hospital vs hospital) and by service (Medicine vs Surgery)

    Time frame: 6 months after last follow-up visit

    Yes/No according to Système national d'information inter-régimes de l'Assurance maladie (SNIIRAM) database

  4. Concordance between vaccines dispensed and vaccines recorded in the SNIRRAM database between groups and stratified by type of establishment (University hospital vs hospital) and by service (Medicine vs Surgery)

    Time frame: 6 months after discharge

    Yes/No

  5. Prescription of vaccines at discharge by the doctor between groups and stratified by type of establishment (University hospital vs hospital) and by service (Medicine vs Surgery)

    Time frame: at discharge (average 5 days after hospitlization)

    Yes/No

  6. Notification of requirement for vaccine between groups and stratified by type of establishment (University hospital vs hospital) and by service (Medicine vs Surgery)

    Time frame: at discharge (average 5 days after hospitlization)

    Yes/No

  7. Transmission of letter highlighting the absence of vaccination by the pharmacy to the patient's doctor between groups and stratified by type of establishment (University hospital vs hospital) and by service (Medicine vs Surgery)

    Time frame: at discharge (average 5 days after hospitlization)

    Yes/No

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: OPTIVACC

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 29, 2021
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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