Ofloxacin Concentration-toxicity Relationship in the Elderly

Bone and Joint Infection Clinical Trial

— ROSCO  

Official title:

Determination of a Trough Serum Concentration of Ofloxacin Associated to Increase in Side Effects Frequency in Elderly Treated for Bone and Joint Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04496024
• Other study ID #: PI2019_843_0018
• Status: Recruiting
• Phase: N/A
• Start date: June 2, 2020
• Est. completion date: August 2023

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Youssef BENNIS, MD
• Phone: (33)32208700
• Email: bennis.youssef[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: August 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adverse Drug Reactions
• Arthritis, Infectious
• Bone and Joint Infection
• Drug-Related Side Effects and Adverse Reactions
• Infections
• Ofloxacin
• Therapeutic Drug Monitoring

Intervention

Drug:
• ofloxacin
ofloxacin treatment in patients with bone and joint infections

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

Biological:
• Ofloxacin Serum concentration
Serum concentration of ofloxacin will be measured at Day 3 (Cmin and Cmax), Day 21 and Day 42 (Cmin).

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	day 3