Ofloxacin Concentration-toxicity Relationship in the Elderly

Not Applicable

Recruiting

• Conditions: Therapeutic Drug Monitoring; Ofloxacin; Bone and Joint Infection; Adverse Drug Reactions

• Registration Number: NCT04496024
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-02
• Study First Submitted: 2020-07-29
• Study First Submitted QC: 2020-07-29
• Study First Posted: 2020-08-03
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-22
• Primary Completion: 2023-06
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Frequency of one adverse reaction attributable to ofloxacin in patients with bone and joint infections	day 3	Frequency of at least one adverse reaction attributable to ofloxacin in patients with bone and joint infections

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France