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

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

Study Overview

• Status: Completed
• Conditions: Streptococcus Pneumoniae Infection
• Intervention / Treatment: Other: Structured medico-pharmaceutical collaboration

• Study Type: Interventional
• Enrollment (Actual): 646
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Alès, France
    • CH Alès Cévennes
  • Bagnols-sur-Cèze, France
    • CH de Bagnols sur Cèze
  • Montauban, France
    • CH de Montauban
  • Montpellier, France
    • CHU de Montpellier
  • Nîmes, France
    • CHU de Nîmes
  • Perpignan, France
    • CH de Perpignan
  • Saint-Gaudens, France
    • CH Comminges Pyrénées
  • Sète, France
    • CH du Bassin de Thau
  • Toulouse, France
    • CHU de Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard care
Experimental: Structured medico-pharmaceutical collaboration	Other: Structured medico-pharmaceutical collaboration; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Full vaccination coverage (2 doses) between groups	Yes/No, confirmed by the administrator	6 months after discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Full vaccination coverage (2 doses) between groups, stratified by type of establishment (University hospital vs hospital) and by service (Medicine vs Surgery)	Yes/No, confirmed by the administrator	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)	Yes/No, confirmed by the administrator	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)	Yes/No according to Système national d'information inter-régimes de l'Assurance maladie (SNIIRAM) database	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)	Yes/No	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)	Yes/No	at discharge (average 5 days after hospitlization)
Notification of requirement for vaccine between groups and stratified by type of establishment (University hospital vs hospital) and by service (Medicine vs Surgery)	Yes/No	at discharge (average 5 days after hospitlization)
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)	Yes/No	at discharge (average 5 days after hospitlization)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Florent Dubois, Centre Hospitalier Universitaire de Nîmes

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2022
• Primary Completion (Actual): June 12, 2024
• Study Completion (Actual): June 12, 2024

Study Registration Dates

• First Submitted: September 7, 2021
• First Submitted That Met QC Criteria: September 16, 2021
• First Posted (Actual): September 29, 2021

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Pneumococcal Infections
• Other Study ID Numbers: PHRC-I/2019/FD-01; 2020-A01581-38 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No