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