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

NCT05248490 | Completed

• 2 other identifiers: APHP2114222021-A02433-38
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bone and Joint Infection

Keywords

osteo articular infection; adverse event; antibiotic treatment; pharmaceutical interview

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Patient knowledge assessment

  at day 7

Study Arms (2)

Patients with pharmaceutical interview

EXPERIMENTAL

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

Other: pharmaceutical interview

Patients without pharmaceutical interview

NO INTERVENTION

Control group without interview

Interventions

pharmaceutical interview OTHER

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

Patients with pharmaceutical interview

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Pharmacy of Ambroise-Paré hospital, APHP

Boulogne-Billancourt, 92100, France

Location

Study Officials

• Thomas Tritz, PharmD

  Pharmacy of Ambroise-Paré hospital, APHP

  PRINCIPAL INVESTIGATOR

• Christophe Menigaux, MD

  Orthopedic surgery department, Ambroise Paré hospital, APHP

  STUDY CHAIR

• Nathalie Dournon, MD

  Infectiology mobile team, Ambroise Paré hospital, APHP

  STUDY CHAIR

• Jessica Berdougo Berdougo, PharmD

  Pitié-Salepetrière hospital, APHP

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: February 21, 2022
• Study Start: March 22, 2022
• Primary Completion: June 5, 2024
• Study Completion: June 14, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)