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Phase 4 N=249 Randomized Treatment

Daptomycin Versus Vancomycin in Participants With Skin Infections Due to MRSA

Staphylococcal Skin Infections

Enrolled (actual)
249
Serious AEs
10.7%
Results posted
Jul 2015
Primary outcome: Primary: Infection-Related Hospital Length of Stay — 91.46; 93.23 Hours

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Daptomycin (Drug); Vancomycin (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Primary completion
Sep 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Infection-Related Hospital Length of Stay
91.46; 93.23
SECONDARY
Mean Change From Baseline to Hospital Discharge in Pain According to the Brief Pain Inventory-Short Form (BPI-SF)
-2.08; -2.54
SECONDARY
Mean Change From Baseline to Hospital Discharge in Participant-reported Health-related Quality of Life (HRQoL)
0.12; 0.18
SECONDARY
Participant Global Impression of Improvement (PGI-I) at Hospital Discharge
2.05; 1.80
SECONDARY
30-day cSSSI-related Hospital Readmission Rates
5; 2
SECONDARY
cSSSI-related Medical Resource Utilization and Costs
10441.30; 9894.34; 11085.57; 10397.24

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.

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
  • 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 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 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01419184). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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