Ofloxacin Concentration-toxicity Relationship in the Elderly

Overview

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.

Full Title of Study: “Determination of a Trough Serum Concentration of Ofloxacin Associated to Increase in Side Effects Frequency in Elderly Treated for Bone and Joint Infection”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2023

Interventions

  • Drug: ofloxacin
    • ofloxacin treatment in patients with bone and joint infections
  • Other: questionnaire
    • questionnaire of ofloxacine side effects will be completed by the clinician at Day 3, Day 21 and Day 42
  • Biological: Ofloxacin Serum concentration
    • Serum concentration of ofloxacin will be measured at Day 3 (Cmin and Cmax), Day 21 and Day 42 (Cmin).

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire, Amiens
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Youssef BENNIS, MD, Principal Investigator, CHU Amiens
    • Jean Philippe LANOIX, MD, Study Chair, CHU Amiens
  • Overall Contact(s)
    • Youssef BENNIS, MD, (33)32208700, bennis.youssef@chu-amiens.fr

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