Ofloxacin blood levels and side effects in older adults with bone and joint infections.
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
Run by Centre Hospitalier Universitaire, Amiens · NCT04496024 · Data updated 2026-11-12
This project will test whether higher blood levels of ofloxacin on day 3 cause more side effects in people over 65 being treated for bone and joint infections.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 65 Years and up |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Status | Recruiting |
| Started | June 2, 2020 |
| Main results expected | June 2026 |
| Study ends | August 2026 |
| Registry record updated | June 10, 2025 |
| Trial ID | NCT04496024 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are consenting patients over 65 hospitalized at CHU Amiens for uncomplicated bone or joint infections who are switching to oral ofloxacin and have no liver or biliary disease or contraindications.
✕Probably not a fit
Patients under 65, those not treated with ofloxacin, or those with liver/biliary injury or other contraindications to ofloxacin are unlikely to benefit from this project.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Older patients hospitalized for uncomplicated bone or joint infections who switch to oral ofloxacin will have residual serum ofloxacin measured on day 3 and complete a questionnaire about possible side effects. The team will link individual day-3 concentrations with the occurrence of at least one adverse effect judged attributable to ofloxacin. If an association is found, the analysis will estimate a threshold concentration associated with increased toxicity. The single-center design uses routine clinical monitoring and targeted sampling to inform therapeutic drug monitoring decisions.
Why it matters
Potential benefit: If a toxicity threshold is identified, clinicians could use blood-level monitoring to adjust dosing and reduce side effects in older patients.
How similar studies have gone: Therapeutic drug monitoring has guided dosing for other antibiotics, but a clear serum concentration-toxicity threshold for ofloxacin in the elderly is novel and largely untested.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
CHU Amiens
Amiens, France Recruiting
Study contacts
- Principal investigator: Youssef BENNIS, MD — CHU Amiens
- Study coordinator: Youssef BENNIS, MD
- Email: bennis.youssef@chu-amiens.fr
- Phone: (33)32208700
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.