Compliance and Tolerance to Oral AntiBiotherapy in Osteoarticular Infections (OTABIO)

NCT ID: NCT05202964

Last Updated: 2025-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-13

Study Completion Date

2026-09-30

Brief Summary

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Bone and joint infections (BJI) are most often bacterial infections that can occur after surgery or de novo. They are rarely fatal in the short term, but are associated with significant morbidity, impaired quality of life and significant costs. Treatment of BJI is based on antibiotic therapy, often combined with surgery. Antibiotic therapy, at high doses, lasts a minimum of 6 weeks. It can be responsible for severe adverse effects. These characteristics (prolonged duration, multiple daily doses, and adverse effects) are known to negatively affect treatment adherence in general.

Detailed Description

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Conditions

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Drug-Related Side Effects and Adverse Reactions Treatment Adherence and Compliance

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Tolerance and adherence to oral antibiotics in patients managed for BJI

Patients having a BJI treated by surgery and taking at least one oral antibiotic after the surgery

Tolerance and adherence to oral antibiotics in patients managed for BJI

Intervention Type OTHER

Adherence will be measured 6 weeks (S6) and 3 months (M3) after the surgery. Tolerance will be mesured at baseline, and at 6 weeks (S6) and 3 months (M3) after the surgery.

The compliance data collected will be compared by two methods (electronic pill dispensers and questionnaire).

Patients will respond to a questionnaire about the tolerance of intraveinous antibiotics (between surgery and baseline) and oral antibiotics at baseline, and during the consultation at S6 and M3.

Responses to the compliance questionnaire will be collected during a telephone interview by a member of the Croix-Rousse pharmacy at S6 and M3. The pill organizer data from S6 and M3 will be transferred to the software by a nurse.

Interventions

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Tolerance and adherence to oral antibiotics in patients managed for BJI

Adherence will be measured 6 weeks (S6) and 3 months (M3) after the surgery. Tolerance will be mesured at baseline, and at 6 weeks (S6) and 3 months (M3) after the surgery.

The compliance data collected will be compared by two methods (electronic pill dispensers and questionnaire).

Patients will respond to a questionnaire about the tolerance of intraveinous antibiotics (between surgery and baseline) and oral antibiotics at baseline, and during the consultation at S6 and M3.

Responses to the compliance questionnaire will be collected during a telephone interview by a member of the Croix-Rousse pharmacy at S6 and M3. The pill organizer data from S6 and M3 will be transferred to the software by a nurse.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* ≥ 18 years
* Diagnosis of osteoarticular infection
* Treatment with at least one oral antibiotic for a minimum expected duration ≥ 6 weeks with an expected end of treatment date
* Patient who was informed and did not object to participate in the study

Exclusion Criteria

* Treatment for BJI with oral antibiotic without end of treatment date
* treatment for BJI with parenteral antibiotic only
* patient who doesn't have a telephone number or who doesn't want to give it
* Adults subject to a legal protection measure
* Pregnant or breastfeeding women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Valérie MIRABET

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Hospices Civils de Lyon

Lyon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Tristan FERRY, MD, PHD

Role: CONTACT

4 26 73 29 38 ext. +33

Facility Contacts

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Tristan FERRY

Role: primary

4 26 73 29 38 ext. +33

Other Identifiers

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2021-A02134-37

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL21_0905

Identifier Type: -

Identifier Source: org_study_id

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