Back to resultsOfloxacin Concentration-toxicity Relationship in the Elderly (ROSCO)
Primary Purpose
Ofloxacin, Bone and Joint Infection, Therapeutic Drug Monitoring
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ofloxacin
questionnaire
Ofloxacin Serum concentration
Sponsored by
About this trial
This is an interventional treatment trial for Ofloxacin focused on measuring ofloxacin, Bone and Joint Infection, therapeutic drug monitoring, Adverse Drug Reactions
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
Sites / Locations
- CHU AmiensRecruiting
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04496024
First Posted
July 29, 2020
Last Updated
March 21, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT04496024
Brief Title
Ofloxacin Concentration-toxicity Relationship in the Elderly
Acronym
ROSCO
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2, 2020 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ofloxacin, Bone and Joint Infection, Therapeutic Drug Monitoring, Adverse Drug Reactions
Keywords
ofloxacin, Bone and Joint Infection, therapeutic drug monitoring, Adverse Drug Reactions
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ofloxacin
Intervention Description
ofloxacin treatment in patients with bone and joint infections
Intervention Type
Other
Intervention Name(s)
questionnaire
Intervention Description
questionnaire of ofloxacine side effects will be completed by the clinician at Day 3, Day 21 and Day 42
Intervention Type
Biological
Intervention Name(s)
Ofloxacin Serum concentration
Intervention Description
Serum concentration of ofloxacin will be measured at Day 3 (Cmin and Cmax), Day 21 and Day 42 (Cmin).
Primary Outcome Measure Information:
Title
Frequency of one adverse reaction attributable to ofloxacin in patients with bone and joint infections
Description
Frequency of at least one adverse reaction attributable to ofloxacin in patients with bone and joint infections
Time Frame
day 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Youssef BENNIS, MD
Phone
(33)32208700
Email
bennis.youssef@chu-amiens.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Youssef BENNIS, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean Philippe LANOIX, MD
Organizational Affiliation
CHU Amiens
Official's Role
Study Chair
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80480
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Youssef Bennis, MD
Phone
03 22 08 70 00
Email
bennis.youssef@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Jean Philippe LANOIX, MD
First Name & Middle Initial & Last Name & Degree
Jean-Luc SCHMIT, MD
First Name & Middle Initial & Last Name & Degree
Youssef EL SAMAD, MD
First Name & Middle Initial & Last Name & Degree
Benoît BRUNSCHWEILER, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ofloxacin Concentration-toxicity Relationship in the Elderly
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