An interventional study of Vancomycin in Infection, sponsored by M.D. Anderson Cancer Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-03-18.
Sponsored by M.D. Anderson Cancer Center · Not applicable, Interventional, and Treatment
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.
6,702 studies on the registry are indexed under Infections; 801 are open to participants now.
This study's enrollment of 1 is below the median of 120 across 4,205 interventional studies indexed under Infections.
Browse Infections studies →M.D. Anderson Cancer Center is the lead sponsor of 3,044 studies on the registry; 578 are open to participants now.
Of its 608 completed or terminated interventional studies of FDA-regulated products, 407 (67%) have results posted.
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Exclusion Criteria:
Loading dose 30 mg/kg via central or peripheral intravenous infusion. Subsequent doses of vancomycin (15 mg/kg) are considered standard of care.
Drug: Vancomycin
Loading dose 30 mg/kg via central or peripheral intravenous infusion. Subsequent doses of vancomycin (15 mg/kg) are considered standard of care.
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).
Time frame: Up to 5 days
Recruitment Period: June 21, 2010 to January 4, 2012. All recruitment done at The University of Texas MD Anderson Cancer Center.
| Milestone | Vancomycin Loading |
|---|---|
| Started | 1 |
| Completed | 1 |
| Not completed | 0 |
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).
No measurements were reported for this outcome.
Collected over 2 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vancomycin Loading | — | 0/1 (0%) | 0/1 (0%) |
| Age, Categorical(Participants) | Vancomycin Loading |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Vancomycin Loading |
|---|---|
| Female | 1 |
| Male | 0 |
| Region of Enrollment(participants) | Vancomycin Loading |
|---|---|
| United States | 1 |
This study is terminated, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vancomycin