Status:
COMPLETED
Daptomycin Versus Vancomycin in Participants With Skin Infections Due to MRSA
Lead Sponsor:
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Staphylococcal Skin Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 c...
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 re...
Eligibility Criteria
Inclusion
- ≥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
Exclusion
- 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
Key Trial Info
Start Date :
September 9 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2012
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT01419184
Start Date
September 9 2011
End Date
October 5 2012
Last Update
September 5 2018
Active Locations (26)
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1
Mobile, Alabama, United States
2
Chula Vista, California, United States
3
Escondido, California, United States
4
La Mesa, California, United States