Impact of Pharmaceutical Interviews Regarding the Management of Adverse Effects Related to the Antibiotic Therapy Used to Treat Osteoarticular Infections During Return Home

Bone and Joint Infection Clinical Trial

— EFIRAD  

Official title:

Impact of Pharmaceutical Interviews Regarding the Management of Adverse Effects Related to the Antibiotic Therapy Used to Treat Osteoarticular Infections During Return Home

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05248490
• Other study ID #: APHP211422
• Secondary ID: 2021-A02433-38
• Status: Completed
• Phase: N/A
• Start date: March 22, 2022
• Est. completion date: April 26, 2024

Study information

• Verified date: April 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective is to evaluate the impact of Pharmaceutical Interviews in the patient self-management of non-severe side effects caused by antibiotics prescribed for the treatment of osteoarticular infections when the patient returns home.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 26, 2024
• Est. primary completion date: April 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient > or =18 years;
• Informed consent signed;
• French-speaking and reading;
• Affiliated to a social insurance;
• Benefiting from medical and surgical care for an osteoarticular infection;
• Treated with an oral antibiotic therapy on discharge from hospital.
• Indication of the antibiotic therapy osteoarticular infection;
• Return home immediately after discharge.

Exclusion Criteria:

• Refusal to participate
• Protected adult patient, under guardianship or curatorship.
• Minor patient
• Patient benefiting from an AME.
• Pregnant or breastfeeding woman.
• Non-French speaking patient.
• Patient unable to understand the course of the study.
• Patient with a documented history of cognitive or psychiatric disorders.
• Patient treated with oral antibiotic therapy for an indication other than osteoarticular infection.
• Patient treated with parenteral antibiotic therapy.
• Discharge: Institution (EHPAD), rehabilitation or other health establishment.
• Patient systematically using one of the symptomatic treatments proposed in the discharge prescription before hospitalization.

Related Conditions & MeSH terms

• Bone and Joint Infection
• Communicable Diseases
• Infections

Intervention

Other:
• pharmaceutical interview
Pharmaceutical interview with pharmacist: to be informed treatment taken and related SAE informations at the end of hospitalization

Locations

Country	Name	City	State
France	Pharmacy of Ambroise-Paré hospital, APHP	Boulogne-Billancourt

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse effects self-management measurement	Phone call to evaluate the self-management of adverse effects. Self-management evaluation (optimal choice/non-optimal choice) performs thanks to the use of a standardized decision-tree.; Proportion of patients with an optimal or non-optimal self-management.	at day 7
Primary	Adverse effects self-management measurement	Phone call to evaluate the self-management of adverse effects. Self-management evaluation (optimal choice/non-optimal choice) performs thanks to the use of a standardized decision-tree.; Proportion of patients with an optimal or non-optimal self-management.	at day 14
Secondary	Patient knowledge assessment	Questionnaire, 12 points: proportion of patients reaching a score upper than 10; proportion of patients reaching a score between 6 and 9; proportion of patients reaching a score lower than 6	at day 7