NCT04496024 Ofloxacin Concentration-toxicity Relationship in the Elderly
| NCT ID | NCT04496024 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire, Amiens |
| Condition | Ofloxacin |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2020-06-02 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 110 participants in total. It began in 2020-06-02 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Youssef BENNIS, MD
PRINCIPAL INVESTIGATOR
CHU Amiens
Frequently Asked Questions
Who can join the NCT04496024 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Ofloxacin. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04496024 currently recruiting?
Yes, NCT04496024 is actively recruiting participants. Contact the research team at bennis.youssef@chu-amiens.fr for enrollment information.
Where is the NCT04496024 trial being conducted?
This trial is being conducted at Amiens, France.
Who is sponsoring the NCT04496024 clinical trial?
NCT04496024 is sponsored by Centre Hospitalier Universitaire, Amiens. The principal investigator is Youssef BENNIS, MD at CHU Amiens. The trial plans to enroll 110 participants.