Vancomycin Versus Daptomycin for the Treatment of Methicillin-resistant Staphylococcus Aureus Bacteremia Due to Isolates With High Vancomycin Minimum Inhibitory Concentrations (MICs)

NCT01287832 | Terminated Phase 4 Results DMC

• 2 other identifiers: SJ1210-01IND 109,614
• Study Type: interventional
• Target: 11
• Locations: 0 countries
• Sites: N/A

Brief Summary

There is an increased failure rate for the treatment of Staphylococcus Aureus Bacteremia (SAB) with traditional doses of vancomycin, the standard of care for patients with MRSA bacteremia over the last 40 years. This has been largely attributed to isolates with increased resistance to vancomycin (increased MIC). Daptomycin is an antibiotic that was approved several years ago for the treatment of SAB and is being increasingly used for MRSA bacteremia due to isolates with increased MIC. Increased doses have been recommended for both of these drugs in the treatment of this infection without a trial demonstrating their relative efficacy or safety at higher doses. This study will randomize patients with SAB due to MRSA with an increased MIC to determine the relative efficacy and safety of vancomycin and daptomycin used at higher than traditional doses.

Conditions

Bacteremia

Keywords

Methicillin-resistant; Staphylococcus aureus

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Clinical Success at Test of Cure Visit.

  Clinical success is the absence of treatment failures. Treatment failures will include death, clinical failure, microbiologic failure, or an adverse event requiring a change in therapy or discontinuation in therapy.

  30-42 days post-treatment

Secondary Outcomes (1)

• Adverse Event Rate in Each Arm, Including the Nephrotoxicity and Skeletal Muscle Toxicity

  30-42 days post-treatment

Study Arms (2)

High dose vancomycin

ACTIVE COMPARATOR

Vancomycin dosed to achieve a trough of 15-20 microgram/mL.

Drug: Vancomycin

High-dose daptomycin

EXPERIMENTAL

Daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)

Drug: Daptomycin

Interventions

Vancomycin DRUG

Vancomycin dosed to achieve a trough of 15-20 microgram/mL.

High dose vancomycin

Daptomycin DRUG

High-dose daptomycin

Eligibility Criteria

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

You may qualify if:

• years of age or older
• Signed informed consent
• All cases of suspected MRSA bacteremia as determined by a patient with at least one blood culture growing gram-positive cocci in clusters with a clinical syndrome consistent with true bacteremia including fever, hypothermia (temperature \< 36.0º C), tachycardia (heart rate \> 100 beats/minute), hypotension (systolic blood pressure \< 90 mm Hg) or other clinical features of sepsis.
• All cases of right-sided native valve endocarditis due to MRSA
• Patients who are diagnosed with left-sided native valve endocarditis after randomization will be continued in the study
• Patients with MRSA bacteremia associated with infected foreign bodies, including vascular prostheses, orthopedic prostheses

Sponsors & Collaborators

• Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA): collaborator
• St. John Health System, Michigan: lead
• Henry Ford Health System: collaborator

MeSH Terms

Conditions

Bacteremia; Staphylococcal Infections

Interventions

Vancomycin; Daptomycin

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gram-Positive Bacterial Infections

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids

Results Point of Contact

• Title: Leonard Johnson MD
• Organization: St. John Hospital and Medical Center

leonard.johnson@stjohn.org

3133438823

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: Division Chief

Study Record Dates

• First Submitted: January 31, 2011
• First Posted: February 1, 2011
• Study Start: June 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: February 10, 2014
• Results First Posted: January 17, 2014

Record last verified: 2014-01