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

November 26, 2025 updated by: Centre Hospitalier Universitaire de Nīmes
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
646

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Full vaccination coverage (2 doses) between groups
Time Frame: 6 months after discharge
Yes/No, confirmed by the administrator
6 months after discharge

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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)
Time Frame: 6 months after discharge
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)
Time Frame: 6 months after discharge
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)
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
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)
Time Frame: 6 months after discharge
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)
Time Frame: at discharge (average 5 days after hospitlization)
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)
Time Frame: at discharge (average 5 days after hospitlization)
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)
Time Frame: at discharge (average 5 days after hospitlization)
Yes/No
at discharge (average 5 days after hospitlization)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nīmes

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Florent Dubois, Centre Hospitalier Universitaire de Nīmes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 19, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 12, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 12, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 7, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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