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Treatment of infections in critically ill patients remains a significant challenge to intensivists world-wide with persisting high mortality and morbidity. Compelling evidence suggests that source control of the pathogen and appropriate antibiotic therapy remain the most important interventions to improve patients' outcome, the latter including the administration of a suitable molecule at an optimized dosage regimen.
Daptomycin is the first representative of a new family of antibiotics, the cyclic lipopeptides. Its bactericidal effect against Gram-positive bacteria, including meticillin-resistant strains, and its low renal toxicity, make it a useful antibiotic in critically ill patients having infections due to resistant Gram positive strains.
Unfortunately, no PK study has been performed in infected critically ill patients without renal replacement therapy. A vast array of pathophysiological changes can occur in infected critically ill patients, leading to changes in volume of distribution and clearance of antibiotics in these patients, which may affect the antibiotic concentration at the target site.
It is therefore important to better characterize daptomycin PK in infected patients with various degrees of renal failure in order to define optimal dosing regimens.
This project aims to identify optimal daptomycin administration schemes in critical care patients with various degrees of renal impairment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daptomycin, IV | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daptomycin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| area under the curve / minimum inhibitory concentration ratio of distribution and elimination of daptomycin in plasma and urine | 12 months | |
| Cmin and Cmax of distribution and elimination of daptomycin in plasma and urine | 12 months | |
| volume of distribution of daptomycin in plasma and urine | 12 months | |
| clearance of distribution and elimination of daptomycin in plasma and urine | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| the clinical and microbiological efficacy during Daptomycine treatment and two weeks after the end of it | Patients will be considered to have clinical failure if they will have no response to the study drug on the basis of ongoing signs and symptoms of infection. Otherwise, patients will be considered to have clinical success. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lasocki S, University Hospital of Angers | Angers | France | 49933 | France | ||
| Asehnoune K, University Hospital of Nantes |
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| renal and muscular tolerance during Daptomycin treatment and two weeks after the end of it |
| 12 months |
| Nantes |
| France |
| 44093 |
| France |
| Seguin P, University Hospital of Rennes | Rennes | France | 35033 | France |
| Ferrandiere M, University Hospital of Tours | Tours | France | 37170 | France |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D017576 | Daptomycin |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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