Ofloxacin Concentration-toxicity Relationship in the Elderly (ROSCO)

Centre Hospitalier Universitaire, Amiens

Status: Enrolling

Conditions: Therapeutic Drug Monitoring; Ofloxacin; Bone and Joint Infection; Adverse Drug Reactions

Treatments: Biological: Ofloxacin Serum concentration; Other: questionnaire; Drug: ofloxacin

Study type: Interventional

Funder types: Other

Identifiers

NCT04496024

PI2019_843_0018

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)