Ofloxacin Concentration-toxicity Relationship in the Elderly

NCT04496024 | Recruiting

• 1 other identifier: PI2019_843_0018
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

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

  day 3

Interventions

ofloxacin DRUG

ofloxacin treatment in patients with bone and joint infections

questionnaire OTHER

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

Ofloxacin Serum concentration BIOLOGICAL

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

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80480, France

RECRUITING

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Interventions

Ofloxacin; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Youssef BENNIS, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Jean Philippe LANOIX, MD

  CHU Amiens

  STUDY CHAIR

Central Study Contacts

Youssef BENNIS, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 3, 2020
• Study Start: June 2, 2020
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)