Ofloxacin Concentration-toxicity Relationship in the Elderly

Recruiting now · Not applicable

Conditions studied: Ofloxacin, Bone and Joint Infection, Therapeutic Drug Monitoring, Adverse Drug Reactions

In brief

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.

Key facts

Study ID

NCT04496024

Run by

Centre Hospitalier Universitaire, Amiens

People needed

110

Starts

2020-06-02

Expected to finish

2026-08-01

Last updated by the study team

2025-06-10

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• CHU Amiens — Amiens, France (enrolling)

Full record on ClinicalTrials.gov

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