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Ofloxacin Concentration-toxicity Relationship in the Elderly

NCT04496024 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-06-10

No results posted yet for this 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.

Conditions

  • Ofloxacin
  • Bone and Joint Infection
  • Therapeutic Drug Monitoring
  • Adverse Drug Reactions

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).

Sponsors & Collaborators

  • Centre Hospitalier Universitaire, Amiens

    lead OTHER

Principal Investigators

  • Youssef BENNIS, MD · CHU Amiens

  • Jean Philippe LANOIX, MD · CHU Amiens

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-02
Primary Completion
2026-06-30
Completion
2026-08-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04496024 on ClinicalTrials.gov