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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

Tracking Information
First Submitted Date  ICMJE July 13, 2010
First Posted Date  ICMJE July 15, 2010
Results First Submitted Date  ICMJE September 23, 2013
Results First Posted Date  ICMJE March 13, 2014
Last Update Posted Date March 13, 2014
Study Start Date  ICMJE July 2010
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2014)
  • Percentage of Participants First Achieving Therapeutic Levels at 36 Hours [ Time Frame: 36 hours ]
    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.
  • Percentage of Participants First Achieving Therapeutic Levels at 12 Hours [ Time Frame: 12 hours ]
    Percentage of patients reaching a therapeutic level defined as greater than 15 mcg/mL
Original Primary Outcome Measures  ICMJE
 (submitted: July 13, 2010)
Therapeutic levels of vancomycin [ Time Frame: 48 hours ]
The objectiveis to determine if therapeutic levels will be reached more rapidly with the implementation of an initial vancomycin loading dose of 30 mg/kg as compared to 15mg/kg.
Change History Complete list of historical versions of study NCT01162733 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Loading Vancomycin Doses in the Emergency Department
Official Title  ICMJE A Randomized Prospective Study of Vancomycin Dosing in the Emergency Department: Will a Loading Dose of 30mg/kg Lead to a More Rapid Attainment of Therapeutic Levels?
Brief Summary In 2008, our ED administered an average of 245 doses of vancomycin per month. Currently there is no consistency in the ED practice in regards to vancomycin dosing. In 2009, the IDSA put forth new recommendations for vancomycin dosing in order to achieve therapeutic levels more rapidly. It has been hypothesized that if therapeutic levels are reached more rapidly then patients will in turn have better clinical outcomes and that the development of resistant organisms will be decreased. Methicillin resistant Staphylococcus aureus (MRSA) has emerged as one of the most deadly pathogens that are currently plaguing our patient population. Vancomycin is one of only a few antibiotics that are effective for treating MRSA. It is imperative that the ED physicians consistently and correctly dose vancomycin in order to give the patients the best chance to fight infection while helping to prevent further resistance in this already highly resistant organism. It is believed this study will reveal that the new dosing recommendations by the IDSA will lead to the achievement of therapeutic levels more rapidly. This information will in turn help to convince ED physicians that a change in current clinical practice is warranted and ultimately lead to better clinically outcomes for the patients.
Detailed Description Recently, the Infectious Disease Society of America (IDSA) has released new dosing recommendations for intravenous (IV) vancomycin. These new recommendations suggest administering an initial dose of 25-30 mg/kg of vancomycin as opposed to 10-15 mg/kg which is more traditionally done. Currently in the Emergency Department (ED) some practitioners are using the new IDSA dosing recommendations for vancomycin, while other practitioners have not changed their clinical practice. There is currently little data available to suggest that implementing these new vancomycin dosing regimens in the ED will achieve therapeutic vancomycin levels more rapidly than our traditional dosing practice.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Infectious Disease
Intervention  ICMJE
  • Drug: Vancomycin
    15mg/kg
  • Drug: Vancomycin
    30mg/kg
Study Arms  ICMJE
  • Active Comparator: Study Drug 1
    Vancomycin 15mg/kg
    Intervention: Drug: Vancomycin
  • Active Comparator: Study Drug 2
    Vancomycin 30mg/kg
    Intervention: Drug: Vancomycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 7, 2012)
99
Original Estimated Enrollment  ICMJE
 (submitted: July 13, 2010)
160
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • At least 18 years of age
  • Treated in Christiana Emergency Department
  • Receiving Vancomycin for an infection or presumed infection
  • Being admitted to Christiana Hospital
  • Planned continued use of Vancomycin after admission.

Exclusion Criteria:

  • Less than 18 years of age
  • Weight greater than 120 kg.
  • Concurrent use of aminoglycosides or acyclovir
  • Sepsis patients being admitted to ICU with presumed diagnosis of pneumonia
  • Patients currently undergoing dialysis
  • Pregnant or breast feeding
  • No plan to continue Vancomycin after admission.
  • Creatinine clearance less than 50ml/min.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01162733
Other Study ID Numbers  ICMJE 30029
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christiana Care Health Services
Study Sponsor  ICMJE Christiana Care Health Services
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Brian Levine, MD Christiana Care Health Services
PRS Account Christiana Care Health Services
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP