Adherence to Oral Antibiotics In Patients With Osteoarticular Infections

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.

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Key information

Conditions

Bone and Joint Infection Adherence, Medication Behavior Health Behavior Medication Adherence Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre de référence des infections ostéo-articulaires de Lyon

Lyon, 69004, France

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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.

Primary outcomes

Proportion of patients with high, moderate and poor adherence

Time frame: 3 months

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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: OBSAIO

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Oct 16, 2017
Registry last updated: Aug 16, 2019

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

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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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