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Completed

NCT Number: NCT05927311

Side Effects of Antibiotics in Bone and Joint Infections

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.

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Key information

Conditions

Bone Infection Joint Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital

Tours, 37044, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Adverse reactions

    Time frame: Day 15

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

  2. Adverse reactions

    Time frame: Day 45

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

  3. Adverse reactions

    Time frame: Day 90

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

Secondary outcomes

  1. Treatment failure

    Time frame: Day 15, day 45, day 90

    In the absence of the criterion of certainty, probable failure is defined by clinical (fever, pain, functional impotence, etc.), radiological (edging, signs of osteitis, etc.) and biological (increased CRP, hyperleukocytosis in the absence of any other cause) arguments.

  2. compliance of treatment

    Time frame: Day 15, day 45, day 90

    Analysis of compliance and discontinuation of treatment, taking into account the adverse reaction profile.

  3. Drug interactions

    Time frame: Day 15, day 45, day 90

    Analysis of drug interactions between antibiotic therapy for BJI and the patient's usual treatments at initiation and at each follow-up consultation.

  4. EQ5D-5L

    Time frame: Day 365

    Quality of life will be assessed using the EuroQol 5 dimensions-5 levels (EQ-5D-5L) score questionnaire at the end of follow-up. Each one of the 5 scales goes from 1 to 5, 1 being the best possible outcome while 5 being the worst.

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study title

Prospective Study : Side Effects of Antibiotics in Bone and Joint Infections

Acronym: PROSEAB

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jul 3, 2023
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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