NCT04496024

Ofloxacin Concentration-toxicity Relationship in the Elderly

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Centre Hospitalier Universitaire, Amiens · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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).

Timeline

• Start date: 2020-06-02
• Primary completion: 2026-06-01
• Completion: 2026-08-01
• First posted: 2020-08-03
• Last updated: 2025-06-10

Locations

1 site across 1 country: France