NCT05927311

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

August 11, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2024

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2025

Completed
Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

12 months

First QC Date

June 12, 2023

Last Update Submit

April 29, 2026

Conditions

Bone InfectionJoint Infection

Keywords

antibiotherapyadverse events

Outcome Measures

Primary Outcomes (3)

  • Adverse reactions

    Changes in number, severity of clinical and biological adverse reactions to antibiotics reported by patients during follow-up of osteoarticular infections.

    Day 15

  • Adverse reactions

    Changes in number, severity of clinical and biological adverse reactions to antibiotics reported by patients during follow-up of osteoarticular infections.

    Day 45

  • Adverse reactions

    Changes in number, severity of clinical and biological adverse reactions to antibiotics reported by patients during follow-up of osteoarticular infections.

    Day 90

Secondary Outcomes (4)

  • Treatment failure

    Day 15, day 45, day 90

  • compliance of treatment

    Day 15, day 45, day 90

  • Drug interactions

    Day 15, day 45, day 90

  • EQ5D-5L

    Day 365

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient over 18 years of age with an osteoarticular infection requiring antibiotherapy of 6 weeks or more

You may qualify if:

  • 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)

You may not qualify if:

  • Opposition to data processing
  • Patient under guardianship or trusteeship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Tours, 37044, France

Location

Study Officials

  • Marion LACASSE

    CHRU de Tours

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2023

First Posted

July 3, 2023

Study Start

August 11, 2023

Primary Completion

August 7, 2024

Study Completion

October 20, 2025

Last Updated

May 6, 2026

Record last verified: 2026-04

Locations

FR(1)