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Trial record 55 of 528 for:    VANCOMYCIN

Utility of Vancomycin Loading: A Pharmacokinetic Analysis in Critically Ill Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01157533
Recruitment Status : Terminated (Low Accrual.)
First Posted : July 7, 2010
Results First Posted : March 18, 2013
Last Update Posted : March 18, 2013
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Infection
Intervention Drug: Vancomycin
Enrollment 1
Recruitment Details Recruitment Period: June 21, 2010 to January 4, 2012. All recruitment done at The University of Texas MD Anderson Cancer Center.
Pre-assignment Details  
Arm/Group Title Vancomycin Loading
Hide Arm/Group Description Loading dose 30 mg/kg via central or peripheral intravenous infusion. Subsequent doses of vancomycin (15 mg/kg) are considered standard of care.
Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title Vancomycin Loading
Hide Arm/Group Description Loading dose 30 mg/kg via central or peripheral intravenous infusion. Subsequent doses of vancomycin (15 mg/kg) are considered standard of care.
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
1
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
1.Primary Outcome
Title Percent of Participants Attaining Target Trough of 15-20 mg/L Following 30 mg/kg Loading Dose
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Unable to complete analysis planned due to low enrollment.
Arm/Group Title Vancomycin Loading
Hide Arm/Group Description:
Loading dose 30 mg/kg via central or peripheral intravenous infusion. Subsequent doses of vancomycin (15 mg/kg) are considered standard of care.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 2 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vancomycin Loading
Hide Arm/Group Description Loading dose 30 mg/kg via central or peripheral intravenous infusion. Subsequent doses of vancomycin (15 mg/kg) are considered standard of care.
All-Cause Mortality
Vancomycin Loading
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vancomycin Loading
Affected / at Risk (%)
Total   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vancomycin Loading
Affected / at Risk (%)
Total   0/1 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ara Vaporciyan, MD, BS/ Professor
Organization: The University of Texas (UT) MD Anderson Cancer Center
EMail: CR_Study_Registration@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01157533     History of Changes
Other Study ID Numbers: 2009-0887
First Submitted: July 5, 2010
First Posted: July 7, 2010
Results First Submitted: February 13, 2013
Results First Posted: March 18, 2013
Last Update Posted: March 18, 2013