Loading Vancomycin Doses in the Emergency Department

NCT ID: NCT01162733

Last Updated: 2014-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2012-06-30

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.

Conditions

Infectious Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study Drug 1

Vancomycin 15mg/kg

Group Type: ACTIVE_COMPARATOR

Vancomycin

Intervention Type: DRUG

15mg/kg

Study Drug 2

Vancomycin 30mg/kg

Group Type: ACTIVE_COMPARATOR

Vancomycin

Intervention Type: DRUG

30mg/kg

Interventions

Vancomycin

15mg/kg

Intervention Type: DRUG

Vancomycin

30mg/kg

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Christiana Care Health Services

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian Levine, MD

Role: PRINCIPAL_INVESTIGATOR

Christiana Care Health Services

Locations

Chrisitana Care Health System-Christiana Hospital

Newark, Delaware, United States

Countries

United States

Other Identifiers

30029

Identifier Type: -

Identifier Source: org_study_id