Determination of a trough serum concentration of ofloxacin associated to increase in side effects frequency in elderly treated for bone and joint infectio

Phase 1

• Conditions: bone and joint infection; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2019-005011-73-FR
• Lead Sponsor: CHU Amiens-Picardie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-29
• Last Update Posted: 15 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

- Patients aged over 65 years hospitalized at the University Hospital of Amiens for an uncomplicated bone and joint infection
- Indication for oral switch to ofloxacin

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 110

Exclusion Criteria

- Any liver or biliary injury
- Any contraindications to ofloxacin

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified