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OpenTrials
Completed

NCT Number: NCT05248490

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pharmacy of Ambroise-Paré hospital, APHP

Boulogne-Billancourt, 92100, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pharmaceutical interview

Other

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

Primary outcomes

  1. Adverse effects self-management measurement

    Time frame: at day 7

    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.

  2. Adverse effects self-management measurement

    Time frame: at day 14

    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.

Secondary outcomes

  1. Patient knowledge assessment

    Time frame: at day 7

    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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: EFIRAD

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 21, 2022
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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