Adherence to Oral Antibiotics In Patients With Osteoarticular Infections

NCT03311113 | Completed

• 1 other identifier: 69HCL17_0467
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bone and Joint Infection; Adherence, Medication

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Drug adherence questionnaire OTHER

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.

Patients with osteoarticular infection

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Centre de référence des infections ostéo-articulaires de Lyon

Lyon, 69004, France

Location

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2017
• First Posted: October 16, 2017
• Study Start: November 16, 2017
• Primary Completion: November 15, 2018
• Study Completion: November 15, 2018
• Last Updated: August 16, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)