Ofloxacin Concentration-toxicity Relationship in the Elderly
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorCentre Hospitalier Universitaire, Amiens
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
ofloxacin
Drugofloxacin treatment in patients with bone and joint infections
questionnaire
Other interventionquestionnaire of ofloxacine side effects will be completed by the clinician at Day 3, Day 21 and Day 42
Ofloxacin Serum concentration
Biological/VaccineSerum concentration of ofloxacin will be measured at Day 3 (Cmin and Cmax), Day 21 and Day 42 (Cmin).
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Frequency of one adverse reaction attributable to ofloxacin in patients with bone and joint infections
Frequency of at least one adverse reaction attributable to ofloxacin in patients with bone and joint infections
Time frame
day 3Sponsors and contacts
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Source ClinicalTrials.gov