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

NCT ID: NCT05248490

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-22

Study Completion Date

2024-06-14

Brief Summary

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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.

Detailed Description

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Conditions

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Bone and Joint Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Patients with pharmaceutical interview

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

Group Type EXPERIMENTAL

pharmaceutical interview

Intervention Type OTHER

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

Patients without pharmaceutical interview

Control group without interview

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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pharmaceutical interview

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Tritz, PharmD

Role: PRINCIPAL_INVESTIGATOR

Pharmacy of Ambroise-Paré hospital, APHP

Christophe Menigaux, MD

Role: STUDY_CHAIR

Orthopedic surgery department, Ambroise Paré hospital, APHP

Nathalie Dournon, MD

Role: STUDY_CHAIR

Infectiology mobile team, Ambroise Paré hospital, APHP

Jessica Berdougo Berdougo, PharmD

Role: STUDY_CHAIR

Pitié-Salepetrière hospital, APHP

Locations

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Pharmacy of Ambroise-Paré hospital, APHP

Boulogne-Billancourt, , France

Site Status

Countries

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France

Other Identifiers

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2021-A02433-38

Identifier Type: REGISTRY

Identifier Source: secondary_id

APHP211422

Identifier Type: -

Identifier Source: org_study_id