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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ofloxacin | Drug | ofloxacin treatment in patients with bone and joint infections | ||
| questionnaire | Other | questionnaire of ofloxacine side effects will be completed by the clinician at Day 3, Day 21 and Day 42 | ||
| Ofloxacin Serum concentration | Biological | Serum concentration of ofloxacin will be measured at Day 3 (Cmin and Cmax), Day 21 and Day 42 (Cmin). |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Youssef BENNIS, MD | Contact | (33)32208700 | bennis.youssef@chu-amiens.fr |
| Name | Affiliation | Role |
|---|---|---|
| Youssef BENNIS, MD | CHU Amiens | Principal Investigator |
| Jean Philippe LANOIX, MD | CHU Amiens | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens | Recruiting | Amiens | 80480 | France |
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| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D015242 | Ofloxacin |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |