RecruitingNot ApplicableNCT04496024

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


Sponsor

Centre Hospitalier Universitaire, Amiens

Enrollment

110 participants

Start Date

Jun 2, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 65 Years

Inclusion Criteria2

  • 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 Criteria4

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGofloxacin

ofloxacin treatment in patients with bone and joint infections

OTHERquestionnaire

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

BIOLOGICALOfloxacin 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04496024


Related Trials