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| ID | Type | Description | Link |
|---|---|---|---|
| 35RC14_9179 | Other Identifier | CHU Rennes |
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Fluoroquinolones (FQ) are among pivotal antibiotic treatments in difficult-to-treat infections. Their efficacy has been shown to be linked to the ratio area under the curve (AUC) of their plasma concentrations over the minimum inhibitory concentration (MIC) of the bacteria treated. Eventually, Forrest et al., reported in gram-negative infections that an AUC/MIC above 125 conducted to a 80 to 90% clinical success whereas success decrease to 30 to 40% in patients with an AUC/MIC below this threshold. These results have been reproduced recently by Zelenitsky et al. in intensive care unit (ICU) patients with threshold similar to the one obtained by Forrest et al. Lastly, elevated concentrations of FQ should be related with the onset of adverse events. Thus, therapeutic drug monitoring (TDM) of FQ appears of potential interest, particularly in case of severe infections (intensive care unit (ICU) patients) or complicated and cost-related infections (osteoarticular infected (OAI) patients), with an increasing level of evidence of its use.
However, FQ TDM requires access to the full AUC of the drug with the need of many samples drawn to patients. This appears to be irreconcilable with clinical practice but can be achieved using population pharmacokinetic (PkPop) modelling. PkPop allows estimating pharmacokinetic parameters of the drug by introducing covariates (demographic, biological, clinical…) and modelling inter-individual pharmacokinetic variability. The model created allows then accessing to individual parameters of patients and thus, estimating concentrations and AUC of the FQ. This approach may also be used in clinical practice to determine a limited sampling strategy allowing an adequate estimation of AUC with a minimum of samples.
Open, prospective, monocentric pharmacokinetic study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients in intensive care | Experimental | 30 patients in intensive care treated with ciprofloxacin IV |
|
| Osteoarticular infected patients | Experimental | 30 patients in orthopedics treated with oral ofloxacin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients in intensive care : infection treated with ciprofloxacin IV | Drug | 8-10 samples per patients on day-4 of their treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration measurement of ciprofloxacin and ofloxacin | measurement between 2 administrations (8-10 samples per patients) | on day-4 of their treatment (steady-state) |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic data | on day-4 of their treatment (steady-state) | |
| Biological data | on day-4 of their treatment (steady-state) | |
| Clinical data |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruno BL Laviolle, MD/PhD | Rennes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rennes University Hospital | Rennes | 35033 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34435591 | Result | Lemaitre F, Fily F, Foulquier JB, Revest M, Jullien V, Petitcollin A, Tattevin P, Tron C, Polard JL, Verdier MC, Comets E, Huten D, Arvieux C, Bellissant E, Laviolle B. Development of a dosing-adjustment tool for fluoroquinolones in osteoarticular infections: The Fluo-pop study. Biomed Pharmacother. 2021 Oct;142:112053. doi: 10.1016/j.biopha.2021.112053. Epub 2021 Aug 19. |
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| Osteoarticular infected patients : infection treated with oral ofloxacin | Drug | 8-10 samples per patients on day-4 of their treatment |
|
|
| on day-4 of their treatment (steady-state) |
| AUC | on day-4 of their treatment (steady-state) |
| MIC | on day-4 of their treatment (steady-state) |
| Cmax | on day-4 of their treatment (steady-state) |
| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D015242 | Ofloxacin |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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