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

NCT05060146 | Completed

• 2 other identifiers: PHRC-I/2019/FD-012020-A01581-38
• Study Type: interventional
• Target: 646
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Streptococcus Pneumoniae Infection

Outcome Measures

Primary Outcomes (1)

• Full vaccination coverage (2 doses) between groups

  Yes/No, confirmed by the administrator

  6 months after discharge

Secondary Outcomes (7)

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

  6 months after discharge

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

  6 months after discharge

• 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)

  6 months after last follow-up visit

• 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)

  6 months after discharge

• 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)

  at discharge (average 5 days after hospitlization)

Study Arms (2)

Standard care

NO INTERVENTION

Structured medico-pharmaceutical collaboration

EXPERIMENTAL

Other: Structured medico-pharmaceutical collaboration

Interventions

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.

Structured medico-pharmaceutical collaboration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• The subject is participating in a category 1 interventional 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (9)

CH Alès Cévennes

Alès, France

Location

CH de Bagnols sur Cèze

Bagnols-sur-Cèze, France

Location

CH de Montauban

Montauban, France

Location

CHU de Montpellier

Montpellier, France

Location

CHU de Nimes

Nîmes, France

Location

CH de Perpignan

Perpignan, France

Location

CH Comminges Pyrénées

Saint-Gaudens, France

Location

CH du Bassin de Thau

Sète, France

Location

CHU de Toulouse

Toulouse, France

Location

Related Publications (1)

• Dubois F, Champiot-Bayard E, Cireasa B, Loubet P, Vallat J, Bonnet J, Jacob V, Puyo P, Pinzar I, Theret S, Dubois E, Peus E, Giraudon L, Roux-Marson C, Fabbro-Peray P, Leguelinel-Blache G, Kinowski JM. Prevention of pneumococcal infections: Impact of structured medico-pharmaceutical collaborative management to improve vaccination coverage of at-risk patients (OPTIVACC study): Protocol for a multicenter randomized stepped -wedge study. Contemp Clin Trials Commun. 2025 Feb 15;44:101462. doi: 10.1016/j.conctc.2025.101462. eCollection 2025 Apr.

  PMID: 40065836 RESULT

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Florent Dubois

  Centre Hospitalier Universitaire de Nīmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Step wedge

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 29, 2021
• Study Start: September 19, 2022
• Primary Completion: June 12, 2024
• Study Completion: June 12, 2024
• Last Updated: December 4, 2025

Record last verified: 2024-10

Locations

FR (9)