Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05060146
Other study ID # PHRC-I/2019/FD-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 19, 2022
Est. completion date September 2024

Study information

Verified date June 2023
Source Centre Hospitalier Universitaire de Nimes
Contact Florent Dubois
Phone 04 66 68 38 44
Email florent.dubois@chu-nimes.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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


Recruitment information / eligibility

Status Recruiting
Enrollment 768
Est. completion date September 2024
Est. primary completion date September 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
France CH Alès Cévennes Alès
France CH de Bagnols sur Cèze Bagnols-sur-Cèze
France CH de Montauban Montauban
France CHU de Montpellier Montpellier
France CHU de Nimes Nîmes
France CH de Perpignan Perpignan
France CH Comminges Pyrénées Saint-Gaudens
France CH du Bassin de Thau Sète
France CHU de Toulouse Toulouse

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Full vaccination coverage (2 doses) between groups Yes/No, confirmed by the administrator 6 months after discharge
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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)
Secondary 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)
Secondary 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)
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05017519 - Epidemiology and Household Transmission of Streptococcus Pneumoniae and Respiratory Syncytial Virus
Recruiting NCT05759520 - Phase III Clinical Trial of 13-valent Pneumococcal Conjugate Vaccine (Multivalent Conjugate) in Infants Phase 3
Completed NCT05361499 - A Controlled Human Pneumococcal Infection Model (PIM) Study N/A
Active, not recruiting NCT03489018 - The Effect of Fractional Doses of Pneumococcal Conjugate Vaccines on Immunogenicity and Carriage in Kenyan Infants Phase 4
Completed NCT03696303 - Determination of the Utility of Pfizer's Pneumococcal Urine Antigen Test in Children 5 Years of Age or Younger With Community Acquired Pneumonia in Guatemala
Active, not recruiting NCT03102840 - Understanding Pneumococcal Carriage and Disease 2017-2020
Completed NCT00189020 - Effect of Two Versus Three Pneumococcal Conjugate Vaccinations Phase 3
Completed NCT02037984 - Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-004) Phase 1/Phase 2
Recruiting NCT04944719 - Pneumococcal Nasopharyngeal Colonization as Predictor of Community-Acquired Pneumonia (CAP) in Adults With Chronic Diseases.
Completed NCT03384589 - CIRN Pneumococcal Conjugate Vaccine 1 vs. 2 Dose Priming Study Phase 2/Phase 3