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Side Effects of Antibiotics in Bone and Joint Infections

NCT ID: NCT05927311

Last Updated: 2024-12-05

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

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-11

Study Completion Date

2025-08-31

Brief Summary

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Treatment for bone and joint infection (BJI) is not standardized, which allows a wide range of antibiotic therapy to potentially be given, most often in high doses over long periods of time. Patients are regularly confronted with the adverse effects of these antibiotics, which can lead to loss of adherence and treatment failure. The frequency, severity and impact on quality of life of the adverse effects of long-term antibiotics will be studied in a cohort followed for one year.

Detailed Description

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Treatment for bone and joint infection is not standardized, which allows a wide range of antibiotic therapy to potentially be given, most often in high doses over long periods of time. Patients are regularly confronted with the adverse effects of these antibiotics, which can lead to loss of adherence and treatment failure. Although patients with BJI receive regular follow-up, the impact of adverse events during treatments lasting more than a month is still poorly developed in the literature.

The frequency, severity and impact on quality of life of the adverse effects of long-term antibiotics will be studied in a cohort followed for one year.

The investigators believe that this study will improve the management of osteoarticular infections through a better understanding of the adverse effects associated with prolonged, high-dose antibiotic therapy, and encourage more multidisciplinary follow-up.

Conditions

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Bone Infection Joint Infection

Keywords

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antibiotherapy adverse events

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patient over 18 years of age
* Microbiologically proven osteoarticular infection with or without material, requiring antibiotic therapy (single or multiple) of 6 weeks or more
* Oral antibiotic therapy (minimum 4 weeks)

Exclusion Criteria

* Opposition to data processing
* Patient under guardianship or trusteeship
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marion LACASSE

Role: PRINCIPAL_INVESTIGATOR

CHRU de Tours

Locations

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University Hospital

Tours, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Marion LACASSE

Role: CONTACT

Phone: 0247476028

Email: [email protected]

Anne-Elisabeth ROYERE

Role: CONTACT

Email: [email protected]

Facility Contacts

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Marion LACASSE

Role: primary

Other Identifiers

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DR230121-PROSEAB

Identifier Type: -

Identifier Source: org_study_id