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Low Accrual.
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The goal of this clinical research study is to learn if giving a larger than normal "loading dose" of the antibiotic vancomycin before starting standard vancomycin dosing can help patients reach and maintain the needed blood-level of the antibiotic during treatment.
The Study Drug:
Vancomycin is an antibiotic used to treat serious, life-threatening infections caused by bacteria. Researchers want to find the best and most effective dose and blood-level of the drug that may have the best effect against bacteria.
Study Drug Administration:
If your doctor believes you are eligible, and you agree to take part in this study, you will be given a "loading dose" of vancomycin that is about twice as large as the standard dose. The dose amounts will be based on your body weight. Doses can be given every 8-12 hours, depending on your level of kidney function.
Study Procedures:
Blood (about 1 teaspoon each time) will be drawn for pharmacokinetic (PK) testing and to check your kidney function. PK testing measures the amount of study drug in the body at different time points. PK blood samples will be drawn just after the loading dose, and then just before each standard dose of vancomycin (up to 5 samples total). When possible, the PK sample may be drawn through a central venous catheter or line you already have placed, to avoid extra "needle sticks."
The study staff will collect information about your health and any side effects you may be having for 7 days.
Length of Study:
Treatment with vancomycin may be stopped early if you experience intolerable side effects or the doctor thinks you can stop taking the drug early.
This is an investigational study. Vancomycin is FDA approved and commercially available for use in treating bacterial infection. The use of a loading dose for vancomycin is investigational.
Up to 10 patients will take part in this study. All will be enrolled at M. D. Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vancomycin Loading | Experimental | Loading dose 30 mg/kg via central or peripheral intravenous infusion. Subsequent doses of vancomycin (15 mg/kg) are considered standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vancomycin | Drug | Loading dose 30 mg/kg via central or peripheral intravenous infusion. Subsequent doses of vancomycin (15 mg/kg) are considered standard of care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants Attaining Target Trough of 15-20 mg/L Following 30 mg/kg Loading Dose | Peak level (PK blood samples) drawn 4 hours after the completion of loading dose. Sequential trough levels drawn 30 minutes before each standard vancomycin dose for the next 4 doses. PK testing measures the amount of study drug in the body at different time points, with trough testing following 5 doses (1 dose every 8 to 12 hours). | Up to 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ara Vaporciyan, MD, BS | UT MD Anderson Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| The University of Texas (UT) MD Anderson Cancer Center website | View source |
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Recruitment Period: June 21, 2010 to January 4, 2012. All recruitment done at The University of Texas MD Anderson Cancer Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vancomycin Loading | Loading dose 30 mg/kg via central or peripheral intravenous infusion. Subsequent doses of vancomycin (15 mg/kg) are considered standard of care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vancomycin Loading | Loading dose 30 mg/kg via central or peripheral intravenous infusion. Subsequent doses of vancomycin (15 mg/kg) are considered standard of care. |
| 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 | Percent of Participants Attaining Target Trough of 15-20 mg/L Following 30 mg/kg Loading Dose | Peak level (PK blood samples) drawn 4 hours after the completion of loading dose. Sequential trough levels drawn 30 minutes before each standard vancomycin dose for the next 4 doses. PK testing measures the amount of study drug in the body at different time points, with trough testing following 5 doses (1 dose every 8 to 12 hours). | Unable to complete analysis planned due to low enrollment. | Posted | Up to 5 days |
|
2 months
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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 | Vancomycin Loading | Loading dose 30 mg/kg via central or peripheral intravenous infusion. Subsequent doses of vancomycin (15 mg/kg) are considered standard of care. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ara Vaporciyan, MD, BS/ Professor | The University of Texas (UT) MD Anderson Cancer Center | CR_Study_Registration@mdanderson.org |
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| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
| 0 |
| 1 |
| 0 |
| 1 |
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| D000602 |
| Amino Acids, Peptides, and Proteins |