Daptomycin Versus Vancomycin in Participants With Skin Infections Due to MRSA

Completed · Phase 4

Conditions studied: Staphylococcal Skin Infections

In brief

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.

Key facts

Study ID

NCT01419184

Run by

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

People needed

250

Starts

2011-09-09

Expected to finish

2012-10-05

Last updated by the study team

2018-09-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥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
• 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
• Are suspected or documented to be caused by MRSA
• 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

You may not qualify if…

• 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

Where it is running

• Study site — Mobile, Alabama, United States
• Study site — Chula Vista, California, United States
• Study site — Escondido, California, United States
• Study site — La Mesa, California, United States
• Study site — Oceanside, California, United States
• Study site — Augusta, Georgia, United States
• Study site — Decatur, Georgia, United States
• Study site — Waterloo, Iowa, United States
• Study site — Topeka, Kansas, United States
• Study site — Louisville, Kentucky, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Worcester, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Royal Oak, Michigan, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Albany, New York, United States
• Study site — East Meadow, New York, United States
• Study site — Mineola, New York, United States
• Study site — The Bronx, New York, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Columbus, Ohio, United States
• Study site — Toledo, Ohio, United States
• Study site — Rapid City, South Dakota, United States
• Study site — Austin, Texas, United States

Full record on ClinicalTrials.gov

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