RecruitingNot ApplicableNCT04496024

Ofloxacin Concentration-toxicity Relationship in the Elderly

Determination of a Trough Serum Concentration of Ofloxacin Associated to Increase in Side Effects Frequency in Elderly Treated for Bone and Joint Infection


Sponsor

Centre Hospitalier Universitaire, Amiens

Enrollment

110 participants

Start Date

Jun 2, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Ofloxacin Serum concentration, a drug called ofloxacin, and others for people with adverse drug reactions, bone and joint infection, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 65 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGofloxacin

ofloxacin treatment in patients with bone and joint infections

OTHERquestionnaire

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

BIOLOGICALOfloxacin Serum concentration

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


Locations(1)

CHU Amiens

Amiens, France

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NCT04496024


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