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| ID | Type | Description | Link |
|---|---|---|---|
| 5UL1RR024982-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Research Resources (NCRR) | NIH |
| University of Texas Southwestern Medical Center | OTHER |
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This study will find how weight affects the dosing of a drug called caspofungin. Currently, the amount of caspofungin a patient receives is the same regardless of the patient's weight.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capsofungin | Experimental | Six volunteers will have a body mass index (BMI) less than 25 kg/m2, 6 will have a BMI 25-40 kg/m2, and 6 will have a BMI greater than 40 kg/m2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caspofungin | Drug | Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Clearance of Caspofungin | 0-72 hours (0, 1, 8, 16, 24, 48, and 72 hours) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald Hall, PharmD, MSCS | Texas Tech University HSC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23459494 | Result | Hall RG 2nd, Swancutt MA, Meek C, Leff R, Gumbo T. Weight drives caspofungin pharmacokinetic variability in overweight and obese people: fractal power signatures beyond two-thirds or three-fourths. Antimicrob Agents Chemother. 2013 May;57(5):2259-64. doi: 10.1128/AAC.01490-12. Epub 2013 Mar 4. |
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Volunteers recruited with fliers at medical center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Capsofungin | Six volunteers will have a body mass index (BMI) less than 25 kg/m2, 6 will have a BMI 25-40 kg/m2, and 6 will have a BMI greater than 40 kg/m2. Caspofungin : Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Capsofungin | Six volunteers will have a body mass index (BMI) less than 25 kg/m2, 6 will have a BMI 25-40 kg/m2, and 6 will have a BMI greater than 40 kg/m2. Caspofungin : Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug) |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Total Clearance of Caspofungin | Posted | Mean | Standard Deviation | L/hr | 0-72 hours (0, 1, 8, 16, 24, 48, and 72 hours) |
|
|
72 hours
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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 | Capsofungin | Six volunteers will have a body mass index (BMI) less than 25 kg/m2, 6 will have a BMI 25-40 kg/m2, and 6 will have a BMI greater than 40 kg/m2. Caspofungin : Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Non-systematic Assessment | Classified as mild by the investigators. Resolved about 30 minutes after 650 mg of acteminophen was administered. Volunteer had a history of headaches and migraines. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ronald Hall | Texas Tech UHSC | 214-654-9404 | ronald.hall@ttuhsc.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D009181 | Mycoses |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077336 | Caspofungin |
| ID | Term |
|---|---|
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 18 |
| 2 |
| 18 |
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| Hot flashes and sweating | General disorders | Non-systematic Assessment | Symptoms resolved within a few hours without any intervention. |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D054714 |
| Echinocandins |
| D010456 | Peptides, Cyclic |