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Daptomycin Versus Vancomycin in Participants With Skin Infections Due to MRSA

Information source: Cubist Pharmaceuticals Holdings LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Staphylococcal Skin Infections

Intervention: Daptomycin (Drug); Vancomycin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Cubist Pharmaceuticals

Official(s) and/or principal investigator(s):
Cubist Pharmaceuticals Medical Monitor Medical Monitor, Study Director, Affiliation: Cubist Pharmaceuticals Holdings LLC


This was a real-world, prospective, open-label, multicenter study in which participants were randomized (1: 1) to receive intravenous (IV) vancomycin or IV daptomycin. The purpose of this study is to compare infection-related hospital length of stay, along with a number of participant-reported outcomes, between participants with complicated skin and soft tissue infection treated with daptomycin and vancomycin.

Clinical Details

Official title: A Randomized Study to Evaluate Comparative Effectiveness, Inpatient Resource Utilization, and Cost of Daptomycin vs. Vancomycin in the Treatment of Patients With Complicated Skin and Skin Structure Infections Due to Suspected or Documented Methicillin-resistant Staphylococcus Aureus (MRSA)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Infection-Related Hospital Length of Stay

Secondary outcome:

Mean Change From Baseline to Hospital Discharge in Pain According to the Brief Pain Inventory-Short Form (BPI-SF)

Mean Change From Baseline to Hospital Discharge in Participant-reported Health-related Quality of Life (HRQoL)

Participant Global Impression of Improvement (PGI-I) at Hospital Discharge

30-day cSSSI-related Hospital Readmission Rates

cSSSI-related Medical Resource Utilization and Costs

Detailed description: Eligible participants will be recruited within 24 hours of hospital admission for cSSSI due to suspected or documented Methicillin-resistant Staphylococcus Aureus (MRSA), and who are anticipated to require IV antibiotics effective against MRSA and at least 3 days of hospitalization for management of cSSSI. The primary objective is to compare infection-related hospital length of stay between participants treated with daptomycin and vancomycin. Secondary objectives were to compare participant reported outcomes (pain symptoms and Health Related Quality of Life), 30 day cSSSI-related hospital readmission rates, and cSSSI-related medical resource utilization and costs between participants treated with daptomycin and vancomycin.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- ≥18 years of age

- Primary reason for hospitalization is skin and skin structure infection of a

complicated nature (for example, cellulitis/erysipelas, major cutaneous abscess, or wound infection) that requires IV antibiotic treatment for an anticipated 3 to14 days and hospitalization for management 1. Further defined as infections either involving deeper soft tissue or requiring significant surgical intervention or infections in which the participant has a significant underlying disease state that complicates the response to treatment 2. Are suspected or documented to be caused by MRSA 3. At least 3 of the following clinical signs and symptoms associated with the cSSSI: i. Pain; tenderness to palpation; ii. Elevated temperature (>37. 5°Celsius [99. 5° Farenheit] oral or >38° Celsius [100. 2° Farenheit] rectal); iii. Elevated white blood count (WBC) >10,000/millimeters cubed (mm^3); iv. Swelling and/or induration; erythema; v. Purulent or seropurulent drainage or discharge

- Physician determination that vancomycin or daptomycin would be the initial treatment

of choice for the cSSSI under study (or meets institutional criteria for use of vancomycin or daptomycin)

- Informed consent obtained and signed

- Less than 24 hours post hospital admission

Exclusion Criteria:

- Participants with known bacteremia, osteomyelitis, septic arthritis, or endocarditis

- Conditions where surgery (in and of itself) constitutes curative treatment of the

infection (for example, amputation, incision and drainage)

- cSSSIs which can be managed with an oral antibiotic

- Participants where hospitalization is expected to be <48 hours

- Nosocomial infection

- Participants with necrotizing infections or concomitant gangrene

- Use of systemic antibacterial therapy for the infection for > 24 hours within 48

hours prior to the start of study drug unless (a) the infecting Gram-positive pathogen was resistant in vitro to the therapy or (b) the therapy was administered for 3 or more days with either worsening or no improvement in the infection

- Pathogens identified at study entry to be nonsusceptible to daptomycin or vancomycin

- Participants with neutropenia or compromised immune function (that is, severe

neutropenia [absolute neutrophil count <500 cells per microliter (μL)] or is anticipated to develop severe neutropenia during the study period due to prior or planned therapy)

- Renal insufficiency (calculated creatinine clearance [CLcr] <30 milliliters per

minute or on dialysis)

- Known to be allergic or intolerant to daptomycin or vancomycin

- Pregnant or nursing mothers

- Suspected implanted device or prosthetic as source of infection

- Is considered unlikely to comply with study procedures or to be available for

follow-up contact

Locations and Contacts

Ponce, Puerto Rico

Mobile, Alabama, United States

Chula Vista, California, United States

Escondido, California, United States

LaMesa, California, United States

Oceanside, California, United States

Augusta, Georgia, United States

Decatur, Georgia, United States

Waterloo, Iowa, United States

Topeka, Kansas, United States

Louisville, Kentucky, United States

New Orleans, Louisiana, United States

Worcester, Massachusetts, United States

Detroit, Michigan, United States

Royal Oak, Michigan, United States

Minneapolis, Minnesota, United States

Las Vegas, Nevada, United States

Albany, New York, United States

Bronx, New York, United States

East Meadows, New York, United States

Mineola, New York, United States

Winston-Salem, North Carolina, United States

Columbus, Ohio, United States

Toledo, Ohio, United States

Rapid City, South Dakota, United States

Austin, Texas, United States

Additional Information

Starting date: August 2011
Last updated: June 12, 2015

Page last updated: August 23, 2015

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