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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03311113
Other study ID # 69HCL17_0467
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 16, 2017
Est. completion date November 15, 2018

Study information

Verified date August 2019
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date November 15, 2018
Est. primary completion date November 15, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
France Centre de référence des infections ostéo-articulaires de Lyon Lyon

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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