Prospective Evaluation of a Vancomycin Nomogram With a Continuous Infusion of Vancomycin for Surgical ICU Patients

NCT01786161 | Terminated Phase 4 Results

• 1 other identifier: P 002617
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Vancomycin is an essential antimicrobial which is frequently used in the ICU for suspected methicillin-resistant Staphylococcus aureus (MRSA) infection. Therefore, it is vital to optimize the dosing of vancomycin for this critically ill population. The most efficacious method of administering vancomycin is debated in the literature. Since vancomycin is associated with slow bactericidal activity, it is important to closely monitor serum concentrations so as to achieve early target serum concentration, particularly when treating aggressive S. aureus infections. One study has shown that vancomycin infused continuously may enable faster and more consistent achievement of a therapeutic serum concentration when compared to intermittent infusion. A faster achievement in the goal serum vancomycin concentration would be a protective factor for intensive care unit mortality in patients with MRSA infection. Currently in the surgical ICU (SICU) of our institute, vancomycin is administered based on a vancomycin dosing nomogram. Less than fifty percent of the ICU patients following this nomogram achieved target vancomycin concentration of 15 after 24 hours. To better achieve target vancomycin concentration in 24 hours, we developed a new vancomycin dosing nomogram with a continuous infusion. The aim is to determine which of the two dosing nomogram is more efficient and safer for SICU patients.

Conditions

MRSA - Methicillin Resistant Staphylococcus Aureus Infection

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Achieved the Target Vancomycin Concentration

  The therapeutic level was defined as 15-20 mcg/mL for IIV and 15-25 mcg/mL for CIV

  24 hours

Secondary Outcomes (2)

• Time Required to Reach the Therapeutic Levels

  as long as participants are receiving Vancomycin (mean (SD) 9 (3.8) days for continuous, 8.4 (4.1) days for intermittent)

• Vancomycin Concentration at 24 Hours

  24 hours

Study Arms (2)

Vancomycin with continuous infusion

EXPERIMENTAL

24 hours continuous infusion

Drug: Vancomycin continuous infusion

Vancomycin with intermittent dose interval

ACTIVE COMPARATOR

infusion rate 1000mg/hr

Drug: Vancomycin intermittent dosing interval

Interventions

Vancomycin continuous infusion DRUG

Vancomycin 24 hour intravenous continuous infusion

Vancomycin with continuous infusion

Vancomycin intermittent dosing interval DRUG

Vancomycin intravenous infusion at rate 1000mg/hr

Vancomycin with intermittent dose interval

Eligibility Criteria

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

You may qualify if:

• Male and non-pregnant female \> 18 years of age admitted to Surgical ICUs with suspected infection
• Calculated creatinine clearance \> 60ml/min

You may not qualify if:

• Age \< 18 years
• Allergic to vancomycin
• Calculated creatinine clearance \< 60ml/min
• Pregnant
• Vancomycin administration more than 8 hour and less than 24 hour prior to study enrollment
• Anticipated vancomycin treatment less than 2 days for surgical prophylaxis

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

MGH

Boston, Massachusetts, 02116, United States

Location

Results Point of Contact

• Title: Hsin Lin
• Organization: Massachusetts General Hospital

hlin13@mgh.harvard.edu

6177241314

Study Officials

• Hsin Lin, PharmD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PharmD

Study Record Dates

• First Submitted: February 4, 2013
• First Posted: February 7, 2013
• Study Start: September 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 7, 2017
• Results First Posted: May 5, 2017

Record last verified: 2017-05

Locations

US (1)