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Streptococcus Pneumoniae InfectionOPTIVACCNCT05060146

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

A study testing Structured medico-pharmaceutical collaboration in people with Streptococcus Pneumoniae Infection, run by Centre Hospitalier Universitaire de Nīmes at 9 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Streptococcus Pneumoniae Infection
What is being tested?
Structured medico-pharmaceutical collaboration
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
646 participants
Where
9 sitesFrance
Study dates
19 Sep 2022to 12 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

France9 sites

  • CH Alès Cévennes

    Alès

  • CH de Bagnols sur Cèze

    Bagnols-sur-Cèze

  • CH de Montauban

    Montauban

  • CHU de Montpellier

    Montpellier

  • CHU de Nimes

    Nîmes

  • CH de Perpignan

    Perpignan

  • CH Comminges Pyrénées

    Saint-Gaudens

  • CH du Bassin de Thau

    Sète

  • CHU de Toulouse

    Toulouse

Other trials in France

About this study

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

Being tested
Structured medico-pharmaceutical collaboration
Medical subject headings
Pneumococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Structured medico-pharmaceutical collaborationOther

    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.

Study groups in NCT05060146
Study groupRoleWhat they receive
Standard careNo interventionNot described
Structured medico-pharmaceutical collaborationExperimentalNot described
Receives: Other: Structured medico-pharmaceutical collaboration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Full vaccination coverage (2 doses) between groups

    Yes/No, confirmed by the administrator

    Measured: 6 months after discharge

Secondary outcomes (7)

  1. 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

    Measured: 6 months after discharge

  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)

    Yes/No, confirmed by the administrator

    Measured: 6 months after discharge

  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)

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

    Measured: 6 months after last follow-up visit

  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)

    Yes/No

    Measured: 6 months after discharge

  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)

    Yes/No

    Measured: at discharge (average 5 days after hospitlization)

  6. 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

    Measured: at discharge (average 5 days after hospitlization)

  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)

    Yes/No

    Measured: at discharge (average 5 days after hospitlization)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2021
  2. Study start19 Sep 2022
  3. Primary completion12 Jun 2024
  4. Study completion12 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Step wedge
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
646 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05060146
Sponsor's protocol ID
PHRC-I/2019/FD-01
Other IDs
2020-A01581-38
Acronym
OPTIVACC
Status last verified
Oct 2024
First submitted
7 Sep 2021
Last updated
4 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 40065836

Questions about this trial

What is this clinical trial studying?

A study testing Structured medico-pharmaceutical collaboration in people with Streptococcus Pneumoniae Infection, run by Centre Hospitalier Universitaire de Nīmes at 9 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Full vaccination coverage (2 doses) between groups (time frame: 6 months after discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05060146, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.

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