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RECRUITING
NCT04496024
NA

Ofloxacin Concentration-toxicity Relationship in the Elderly

Sponsor: Centre Hospitalier Universitaire, Amiens

View on ClinicalTrials.gov

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.

Official title: Determination of a Trough Serum Concentration of Ofloxacin Associated to Increase in Side Effects Frequency in Elderly Treated for Bone and Joint Infection

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2020-06-02

Completion Date

2026-08

Last Updated

2025-06-10

Healthy Volunteers

No

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).

Locations (1)

CHU Amiens

Amiens, France