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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04496024

Acronym

ROSCO

Enrollment

110

Registered

2020-08-03

Start date

2020-06-02

Completion date

2026-08-31

Last updated

2025-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ofloxacin, Bone and Joint Infection, Therapeutic Drug Monitoring, Adverse Drug Reactions

Keywords

ofloxacin, Bone and Joint Infection, therapeutic drug monitoring, Adverse Drug Reactions

Brief 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.

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).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Frequency of one adverse reaction attributable to ofloxacin in patients with bone and joint infections	day 3	Frequency of at least one adverse reaction attributable to ofloxacin in patients with bone and joint infections

Countries

France

Contacts

Primary ContactYoussef BENNIS, MD

bennis.youssef@chu-amiens.fr(33)32208700

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026