Daptomycin Versus Vancomycin in Participants With Skin Infections Due to MRSA

NCT ID: NCT01419184

Last Updated: 2018-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-09
• Study Completion Date: 2012-10-05

Brief Summary

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.

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.

Conditions

Staphylococcal Skin Infections

Study Design

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

Study Groups

Daptomycin

4 milligrams per kilogram (mg/kg) daptomycin administered intravenously (IV) once a day until end of antibiotic therapy for complicated skin and skin structure infections (cSSSI) or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.

Group Type: EXPERIMENTAL

Daptomycin

Intervention Type: DRUG

Vancomycin

Vancomycin was reconstituted per the manufacturer's instructions and was dosed per investigator's discretion and was administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occured first. Investigators treated participants according to their usual decision-making and discretion

Group Type: ACTIVE_COMPARATOR

Vancomycin

Intervention Type: DRUG

Interventions

Daptomycin

Intervention Type: DRUG

Vancomycin

Intervention Type: DRUG

Other Intervention Names

Cubicin

Eligibility Criteria

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

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

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cubist Pharmaceuticals Medical Monitor Medical Monitor

Role: STUDY_DIRECTOR

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

Locations

Mobile, Alabama, United States

Chula Vista, California, United States

Escondido, California, United States

La Mesa, 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

East Meadow, New York, United States

Mineola, New York, United States

The Bronx, 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

Ponce, , Puerto Rico

Countries

United States; Puerto Rico

References

Kauf TL, McKinnon P, Corey GR, Bedolla J, Riska PF, Sims M, Jauregui-Peredo L, Friedman B, Hoehns JD, Mercier RC, Garcia-Diaz J, Brenneman SK, Ng D, Lodise T. An open-label, pragmatic, randomized controlled clinical trial to evaluate the comparative effectiveness of daptomycin versus vancomycin for the treatment of complicated skin and skin structure infection. BMC Infect Dis. 2015 Nov 7;15:503. doi: 10.1186/s12879-015-1261-9.

Reference Type: DERIVED

PMID: 26547411 (View on PubMed)

Other Identifiers

DAP-HEOR-10-06

Identifier Type: OTHER

Identifier Source: secondary_id

3009-015

Identifier Type: -

Identifier Source: org_study_id