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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04496024
Other study ID # PI2019_843_0018
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 2, 2020
Est. completion date August 2023

Study information

Verified date March 2023
Source Centre Hospitalier Universitaire, Amiens
Contact Youssef BENNIS, MD
Phone (33)32208700
Email bennis.youssef@chu-amiens.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 110
Est. completion date August 2023
Est. primary completion date June 2023
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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).

Locations

Country Name City State
France CHU Amiens Amiens

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of one adverse reaction attributable to ofloxacin in patients with bone and joint infections Frequency of at least one adverse reaction attributable to ofloxacin in patients with bone and joint infections day 3
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