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Clinical Trials in France / NCT04496024
Recruiting Not applicable

Ofloxacin Concentration-toxicity Relationship in the Elderly

NCT04496024 · tracked via the Priya Life Science France tracker
Sponsor
Centre Hospitalier Universitaire, Amiens
Phase
Not applicable
Started
2020-06-02
Last updated
2025-06-10

Condition(s) studied

OfloxacinBone and Joint InfectionTherapeutic Drug MonitoringAdverse Drug Reactions

Investigational drug(s) / intervention(s)

ofloxacinquestionnaireOfloxacin Serum concentration

ofloxacin: ofloxacin treatment in patients with bone and joint infections

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

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

Study 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.

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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 sites (1)

FacilityCityRegionStatus
CHU Amiens Amiens France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04496024 on ClinicalTrials.gov ↗ ← All trials in France