Ofloxacin Concentration-toxicity Relationship in the Elderly

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

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-02

Study Completion Date

2026-08-31

Brief Summary

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Ofloxacin is a gold standard antibiotic for the treatment of bone and joint infections due to sensible staphylococcus strains. However, in the elderly, inter-individual variability of the pharmacokinetics may reduce the efficacy or increase toxicity. The occurrence of ofloxacin side effects is likely to be increased in case of higher exposition. However, the serum concentration-toxicity relationship has not yet been determined. The purpose of this project is to assess the association between the residual serum concentration of ofloxacin at day 3 and the occurrence of at least one adverse effect attributable to ofloxacin, and determine a threshold toxicity concentration if this association exists.

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Detailed Description

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Conditions

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Ofloxacin Bone and Joint Infection Therapeutic Drug Monitoring Adverse Drug Reactions

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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ofloxacin

ofloxacin treatment in patients with bone and joint infections

Intervention Type DRUG

questionnaire

questionnaire of ofloxacine side effects will be completed by the clinician at Day 3, Day 21 and Day 42

Intervention Type OTHER

Ofloxacin Serum concentration

Serum concentration of ofloxacin will be measured at Day 3 (Cmin and Cmax), Day 21 and Day 42 (Cmin).

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Patients aged over 65 years hospitalized at the University Hospital of Amiens for an uncomplicated bone and joint infections
* Indication for oral switch to ofloxacin

Exclusion Criteria

* Patient refusing to participate in the study
* Patient under guardianship or curators or deprived of public rights
* Any liver or biliary injury
* Any contraindications to ofloxacin

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No