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| ID | Type | Description | Link |
|---|---|---|---|
| HUM00005646 | Other Identifier | U Michigan IRBMED |
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| Name | Class |
|---|---|
| Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | INDUSTRY |
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Daptomycin is an antibiotic that is affective against many strains of antibiotic resistant microorganisms. This antibiotic would be appropriate for use in the intensive care unit (ICU) considering the severity of illness and high risk for infection within this hospital environment. While in the ICU, patients may develop acute renal failure. Approximately 75% of ICU patients who develop acute renal failure will require some form of renal replacement therapy until their kidneys recover. Continuous hemodialysis is becoming one of the most common forms of dialysis in the ICU as it is a gentle type of dialysis provided over longer periods of time. The current data demonstrating the ability of continuous hemodialysis to remove daptomycin from the body is derived from in-vitro trials. The purpose of this trial is to determine the extent of daptomycin removal from critically ill patients receiving continuous hemodialysis. Findings from this trial will be used to develop new dosing recommendations for daptomycin in continuous hemodialysis.
Daptomycin is a FDA approved antibiotic. This pharmacokinetic trial will monitor daptomycin drug concentrations during continuous hemodialysis. The daptomycin concentration profiles developed from this study will assist in developing a dose recommendation that will result in daptomycin levels that are safe and within therapeutic ranges, as previously identified, in critically ill patients with acute renal failure treated with continuous hemodialysis.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daptomycin | Drug | Daptomcyin 8 mg/kg infused intravenously every 48 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Daptomycin Transmembrane Clearance by Continuous Venovenous Hemodialysis | Quantifies the rate of daptomcyin removal by continuous venovenous hemodialysis. | From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis |
| Measure | Description | Time Frame |
|---|---|---|
| Daptomycin Dose Actually Administered | Time of daptomycin administration | |
| Observed Daptomycin Peak Serum Concentration | The maximum concentration of daptomycin in the body after receiving a dose of the drug. This was determined at the end of the daptomycin intravenous infusion at approximately 30 min. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce A Mueller, PharmD | University of Michigan, College of Pharmacy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan University Hospital | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20890189 | Derived | Vilay AM, Grio M, Depestel DD, Sowinski KM, Gao L, Heung M, Salama NN, Mueller BA. Daptomycin pharmacokinetics in critically ill patients receiving continuous venovenous hemodialysis. Crit Care Med. 2011 Jan;39(1):19-25. doi: 10.1097/CCM.0b013e3181fa36fb. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Daptomycin in Continuous Renal Replacement Therapy (CRRT) | This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Daptomycin in Continuous Renal Replacement Therapy (CRRT) | This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Daptomycin Transmembrane Clearance by Continuous Venovenous Hemodialysis | Quantifies the rate of daptomcyin removal by continuous venovenous hemodialysis. | Posted | Mean | Standard Deviation | mL/min | From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis |
|
From time of daptomycin administration to 48 hours post dose
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Daptomycin in Continuous Renal Replacement Therapy (CRRT) | This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis. |
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Transmembrane and total body clearance results limited to continuous venovenous hemodialysis run at ~2 L/h dialysate flow. Clinical outcomes (such as infection cure rate, length of hospital stay, mortality rate) of subjects was not assessed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bruce A. Mueller | University of Michigan College of Pharmacy | 7347636629 | muellerb@umich.edu |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017576 | Daptomycin |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D055666 | Lipopeptides |
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| At the end of the daptomycin intravenous infusion (at approximately 30 minutes) |
| Daptomycin Volume of Distribution at Steady State | Volume of distribution quantifies the distribution of daptomycin between the blood and the rest of the body. The greater the volume of distribtion, the greater the extent of daptomycin distribution throughout the body. | From time of daptomycin administration to 48 hours post dose |
| Daptomycin Total Body Clearance | Total body clearance represents the rate at which daptomycin is removed from the body. In patients treated with continuous venovenous hemodialysis, the major pathways of daptomycin removal likely are: removal by continuuous venovenous hemodialysis (transmembrane clearance) and breakdown by the liver. | From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis |
| Daptomycin Half-life | Half-life describes the time it takes for the concentration of the daptomycin in the body to decrease by one half. | From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis |
| Daptomycin Free Fraction | In the body, daptomcyin may be bound to proteins in the blood or it may not be bound to any proteins (also as the "free" component.) Free fraction describes the percent of daptomycin that is unbound or free. The unbound portion of daptomycin is able to kill bacteria. | From time of daptomycin administration to 48 hours post dose |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
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| Participants |
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| Secondary | Daptomycin Dose Actually Administered | Posted | Mean | Standard Deviation | mg/kg | Time of daptomycin administration |
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| Secondary | Observed Daptomycin Peak Serum Concentration | The maximum concentration of daptomycin in the body after receiving a dose of the drug. This was determined at the end of the daptomycin intravenous infusion at approximately 30 min. | Posted | Mean | Standard Deviation | ug/mL | At the end of the daptomycin intravenous infusion (at approximately 30 minutes) |
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| Secondary | Daptomycin Volume of Distribution at Steady State | Volume of distribution quantifies the distribution of daptomycin between the blood and the rest of the body. The greater the volume of distribtion, the greater the extent of daptomycin distribution throughout the body. | Posted | Mean | Standard Deviation | L/kg | From time of daptomycin administration to 48 hours post dose |
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| Secondary | Daptomycin Total Body Clearance | Total body clearance represents the rate at which daptomycin is removed from the body. In patients treated with continuous venovenous hemodialysis, the major pathways of daptomycin removal likely are: removal by continuuous venovenous hemodialysis (transmembrane clearance) and breakdown by the liver. | Posted | Mean | Standard Deviation | mL/min/kg | From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis |
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| Secondary | Daptomycin Half-life | Half-life describes the time it takes for the concentration of the daptomycin in the body to decrease by one half. | Posted | Mean | Standard Deviation | hours | From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis |
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| Secondary | Daptomycin Free Fraction | In the body, daptomcyin may be bound to proteins in the blood or it may not be bound to any proteins (also as the "free" component.) Free fraction describes the percent of daptomycin that is unbound or free. The unbound portion of daptomycin is able to kill bacteria. | Posted | Mean | Standard Deviation | percent protein binding | From time of daptomycin administration to 48 hours post dose |
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| 0 |
| 8 |
| 0 |
| 8 |
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| D008055 |
| Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |