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

NCT ID: NCT05060146

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

646 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-19

Study Completion Date

2024-06-12

Brief Summary

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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

Detailed Description

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Conditions

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Streptococcus Pneumoniae Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Step wedge
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Structured medico-pharmaceutical collaboration

Group Type EXPERIMENTAL

Structured medico-pharmaceutical collaboration

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Florent Dubois

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nīmes

Locations

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CH Alès Cévennes

Alès, , France

Site Status

CH de Bagnols sur Cèze

Bagnols-sur-Cèze, , France

Site Status

CH de Montauban

Montauban, , France

Site Status

CHU de Montpellier

Montpellier, , France

Site Status

CHU de Nimes

Nîmes, , France

Site Status

CH de Perpignan

Perpignan, , France

Site Status

CH Comminges Pyrénées

Saint-Gaudens, , France

Site Status

CH du Bassin de Thau

Sète, , France

Site Status

CHU de Toulouse

Toulouse, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 40065836 (View on PubMed)

Other Identifiers

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2020-A01581-38

Identifier Type: OTHER

Identifier Source: secondary_id

PHRC-I/2019/FD-01

Identifier Type: -

Identifier Source: org_study_id

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