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OBSAIO
Pilot Study on the ADherence to Oral Antibiotics in Patients With BONE and Joint Infections (ADABONE)
Sponsor study identifier
observational
60
1 country
1
Study Start
November 16, 2017
Actual (reported)Primary Completion
November 15, 2018
Actual (reported)Study Completion
November 15, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 15, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 11, 2017
Actual (reported)October 16, 2017
Actual (reported)November 16, 2017
Actual (reported)November 15, 2018
Actual (reported)November 15, 2018
Actual (reported)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
To evaluate drug adherence to oral antibiotic therapy in patients treated for bone and joint infection for a minimum expected duration of 6 weeks.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Adult patients who are prescribed oral antibiotic as a therapy for bone and joint infection for a minimum duration of 6 weeks
Centre de référence des infections ostéo-articulaires de Lyon
Lyon, 69004, France
60 participants (actual enrollment reported by the registry).
First Submitted
October 11, 2017
First Posted
October 16, 2017
Study Start
November 16, 2017
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
November 15, 2018
Actual (reported)Study Completion
November 15, 2018
Actual (reported)Last Updated
August 16, 2019
Record last verified: 2019-08
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Source: ClinicalTrials.gov.
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