Ofloxacin Concentration-toxicity Relationship in the Elderly
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ofloxacin, questionnaire, Ofloxacin Serum concentration.
- Who it may be relevant to
- Registry conditions: Ofloxacin, Bone and Joint Infection, Therapeutic Drug Monitoring, Adverse Drug Reactions. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- 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).
Primary outcome measures
- Frequency of one adverse reaction attributable to ofloxacin in patients with bone and joint infections [Time frame: day 3]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- CHU Amiens — Amiens
Identifiers
NCT: NCT04496024 · PI2019_843_0018