Adherence to Oral Antibiotics In Patients With Osteoarticular Infections (OBSAIO)

Pilot Study on the ADherence to Oral Antibiotics in Patients With BONE and Joint Infections (ADABONE)

Bone and joint infection (BJI) are bacterial infections that can occur after surgery (nosocomial infections) or de novo. They constitute a public health problem in Western Countries . These infections are often difficult to treat, with a high rate of re-hospitalizations (19.5%) caused by relapses or recurrences. The treatment of Bone and joint infection can be surgical and / or pharmacological . Drug treatment is based on the use of parenteral and / or oral antibiotics. It is a curative therapy in most cases, with a prolonged duration ranging from 6 weeks to several months depending on the lesions .

Medication adherence, is a patients' behavior defined as drug intake with optimal attendance and regularity, as prescribed and explained by the physician. It is a key factor in the success of any drug therapy, as drugs don't work in patients who don't take them..

To the knowledge of investigators, there are no published data on the adherence to antibiotic therapy in patients treated for Bone and joint infection. In addition to its prolonged duration, the antibiotic treatment of the Osteoarticular Infections may require several daily drug intakes and may be responsible for severe adverse effects, these three factors being known to adversely affect adherence.

Prevalence, adherence patterns over time and determinants of adherence in this patient population are not known. Currently, drug adherence is not routinely evaluated and is not considered in the treatment of Bone and joint infection in the Regional Center for Complex Bone and joint infection of the investigators.

A specific study evaluating adherence to antibiotic therapy in patients treated for Bone and joint infection appears to be justified.

Study Overview

• Status: Completed
• Conditions: Adherence, Medication; Bone and Joint Infection
• Intervention / Treatment: Other: Drug adherence questionnaire

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Centre de reference des infections ostéo-articulaires de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients who are prescribed oral antibiotic as a therapy for bone and joint infection for a minimum duration of 6 weeks

Description

Inclusion Criteria:

• Age ≥ 18 years
• Affiliation having a social security
• Diagnosis of Bone and joint infections
• Surgical and clinical management of the infection at Hospices Civils de Lyon
• Oral antibiotic therapy prescribed for a minimal duration of six weeks and a defined duration
• Patient's information given and informed consent obtained

Exclusion Criteria:

• Oral antibiotic therapy for Bone and joint infections with no defined duration (chronic therapy)
• Antibiotic therapy for Bone and joint infections administered by parenteral route only
• Patient without a phone number or refusing to communicate by phone
• Patient with physical or mental disability impeding information and consent
• Patient with physical or mental disability impeding communication by phone

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients with osteoarticular infection; To evaluate drug adherence to oral antibiotic therapy in patients treated for bone and joint infection for a minimum expected duration of 6 weeks.

Other: Drug adherence questionnaire; Adherence to oral antibiotic therapy will be assessed by means of a questionnaire adapted from the French standardized self-assessment questionnaire of Girerd et al. This questionnaire has six questions, each question being associated with a score. Patient's drug adherence is classified into three groups based on the total score: of high, moderate and poor adherence. The questionnaire will be carried by a phone call to the patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with high, moderate and poor adherence	Adherence will be assessed using a questionnaire adapted from the questionnaire of Girerd et al. with 6 questions. Adherence will be assessed during the antibiotic treatment, after 6 weeks of therapy in all patients included. For the included patients still treated at 3 months, it will be evaluated a second time at 3 months.	3 months

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2017
• Primary Completion (Actual): November 15, 2018
• Study Completion (Actual): November 15, 2018

Study Registration Dates

• First Submitted: October 11, 2017
• First Submitted That Met QC Criteria: October 11, 2017
• First Posted (Actual): October 16, 2017

Study Record Updates

• Last Update Posted (Actual): August 16, 2019
• Last Update Submitted That Met QC Criteria: August 14, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: 69HCL17_0467

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No