Loading Vancomycin Doses in the Emergency Department

NCT01162733 | Completed Results DMC

• 1 other identifier: 30029
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Infectious Disease

Keywords

Vancomycin; Therapeutic Levels; Infectious Disease; Recommendations

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants First Achieving Therapeutic Levels at 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.

  36 hours

• Percentage of Participants First Achieving Therapeutic Levels at 12 Hours

  Percentage of patients reaching a therapeutic level defined as greater than 15 mcg/mL

  12 hours

Study Arms (2)

Study Drug 1

ACTIVE COMPARATOR

Vancomycin 15mg/kg

Drug: Vancomycin

Study Drug 2

ACTIVE COMPARATOR

Vancomycin 30mg/kg

Drug: Vancomycin

Interventions

Vancomycin DRUG

15mg/kg

Study Drug 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Christiana Care Health Services: lead

Study Sites (1)

Chrisitana Care Health System-Christiana Hospital

Newark, Delaware, 19718, United States

Location

MeSH Terms

Conditions

Communicable Diseases

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Deb Marco
• Organization: Christiana Care Health System

dmarco@christianacare.org

302 733-4130

Study Officials

• Brian Levine, MD

  Christiana Care Health Services

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2010
• First Posted: July 15, 2010
• Study Start: July 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: March 13, 2014
• Results First Posted: March 13, 2014

Record last verified: 2014-03

Locations

US (1)