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Loading Vancomycin Doses in the Emergency Department (Loaded)

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ClinicalTrials.gov Identifier: NCT01162733
Recruitment Status : Completed
First Posted : July 15, 2010
Results First Posted : March 13, 2014
Last Update Posted : March 13, 2014
Sponsor:
Information provided by (Responsible Party):
Christiana Care Health Services

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Infectious Disease
Intervention Drug: Vancomycin
Enrollment 99
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Study Drug 1 Study Drug 2
Hide Arm/Group Description

Vancomycin 15mg/kg

Vancomycin : 15mg/kg

Vancomycin 30mg/kg

Vancomycin : 30mg/kg

Period Title: Overall Study
Started 49 50
Completed 22 25
Not Completed 27 25
Arm/Group Title Study Drug 1 Study Drug 2 Total
Hide Arm/Group Description

Vancomycin 15mg/kg

Vancomycin : 15mg/kg

Vancomycin 30mg/kg

Vancomycin : 30mg/kg

Total of all reporting groups
Overall Number of Baseline Participants 49 50 99
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Greater than 18 years of age Number Analyzed 49 participants 50 participants 99 participants
49 50 99
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 50 participants 99 participants
Female
24
  49.0%
22
  44.0%
46
  46.5%
Male
25
  51.0%
28
  56.0%
53
  53.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 49 participants 50 participants 99 participants
49 50 99
1.Primary Outcome
Title Percentage of Participants First Achieving Therapeutic Levels at 36 Hours
Hide Description The objective is to determine if therapeutic levels were reached more rapidly with the implementation of an initial vancomycin loading dose of 30 mg/kg as compared to 15mg/kg.
Time Frame 36 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Drug 1 Study Drug 2
Hide Arm/Group Description:

Vancomycin 15mg/kg

Vancomycin : 15mg/kg

Vancomycin 30mg/kg

Vancomycin : 30mg/kg

Overall Number of Participants Analyzed 49 50
Measure Type: Number
Unit of Measure: percentage of participants
20 18
2.Primary Outcome
Title Percentage of Participants First Achieving Therapeutic Levels at 12 Hours
Hide Description Percentage of patients reaching a therapeutic level defined as greater than 15 mcg/mL
Time Frame 12 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Drug 1 Study Drug 2
Hide Arm/Group Description:

Vancomycin 15mg/kg

Vancomycin : 15mg/kg

Vancomycin 30mg/kg

Vancomycin : 30mg/kg

Overall Number of Participants Analyzed 49 50
Measure Type: Number
Unit of Measure: percentage of participants
3 34
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Study Drug 1 Study Drug 2
Hide Arm/Group Description

Vancomycin 15mg/kg

Vancomycin : 15mg/kg

Vancomycin 30mg/kg

Vancomycin : 30mg/kg

All-Cause Mortality
Study Drug 1 Study Drug 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Study Drug 1 Study Drug 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/49 (0.00%)      2/50 (4.00%)    
Cardiac disorders     
New onset Atrial fibrillation   0/49 (0.00%)  0 1/50 (2.00%)  1
Renal and urinary disorders     
Renal failure   0/49 (0.00%)  0 1/50 (2.00%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Study Drug 1 Study Drug 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/49 (6.12%)      3/50 (6.00%)    
Immune system disorders     
Allergic Reaction   2/49 (4.08%)  2 2/50 (4.00%)  2
Skin and subcutaneous tissue disorders     
Flushing   1/49 (2.04%)  1 1/50 (2.00%)  1
Indicates events were collected by systematic assessment
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: Deb Marco
Organization: Christiana Care Health System
Phone: 302 733-4130
EMail: dmarco@christianacare.org
Layout table for additonal information
Responsible Party: Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT01162733     History of Changes
Other Study ID Numbers: 30029
First Submitted: July 13, 2010
First Posted: July 15, 2010
Results First Submitted: September 23, 2013
Results First Posted: March 13, 2014
Last Update Posted: March 13, 2014