Ofloxacin blood levels and side effects in older adults with bone and joint infections.
Determination of a Trough Serum Concentration of Ofloxacin Associated to Increase in Side Effects Frequency in Elderly Treated for Bone and Joint Infection
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Trial ID | NCT04496024 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Amiens
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.