Daptomycin Versus Vancomycin in Patients With Skin Infections Due to MRSA (DAPHEOR1006)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01419184
First received: August 16, 2011
Last updated: October 9, 2012
Last verified: October 2012
  Purpose

Daptomycin has the potential to improve time to clinical response, shorten the number of days patients spend in the hospital and/or the number of days patients require IV antibiotics for the treatment of complicated skin and skin structure infections (cSSSI). This, plus the convenience of once-daily dosing, could translate into health benefits for the patient as well as cost savings for the healthcare system. A pragmatic, comparative effectiveness trial that enrolls a real-world heterogeneous population can provide results (both clinical and economic) that are important to many audiences, i.e., patient, physician, and payer.


Condition Intervention Phase
Staphylococcal Skin Infections
Drug: Daptomycin
Drug: Vancomycin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Study to Evaluate Comparative Effectiveness IRU and Cost of Daptomycin vs. Vancomycin in the Treatment of Patients With cSSSI Due to Suspected or Documented Methicillin-resistant Staphylococcus Aureus (MRSA)

Resource links provided by NLM:


Further study details as provided by Cubist Pharmaceuticals:

Primary Outcome Measures:
  • Infection related hospital length of stay [ Time Frame: variable; anticipated to average 5 to 7 days ] [ Designated as safety issue: No ]

Enrollment: 250
Study Start Date: August 2011
Study Completion Date: October 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Daptomycin Drug: Daptomycin
4 mg/kg should be administered intravenously in 0.9% sodium chloride injection once a day.
Other Name: Cubicin
Active Comparator: Vancomycin Drug: Vancomycin
IV dosed per investigator's discretion

Detailed Description:

OBJECTIVES:

PRIMARY:

• To compare infection-related hospital length of stay between patients treated with daptomycin and vancomycin

SECONDARY:

  • To compare patient-reported outcomes (pain symptoms and Health-Related Quality of Life) between patients treated with daptomycin and vancomycin
  • To compare 30-day cSSSI-related hospital readmission rates between patients treated with daptomycin and vancomycin
  • To compare cSSSI-related medical resource utilization and costs between patients treated with daptomycin and vancomycin
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ≥18 years of age
  2. Primary reason for hospitalization is skin and skin structure infection of a complicated nature (e.g. 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 patient 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 three of the following clinical signs and symptoms associated with the cSSSI:

    i. Pain; tenderness to palpation; ii. Elevated Temperature [>37.5°C (99.5° F) oral or >38° C (100.2° F) rectal]; iii. Elevated White blood count (WBC) >10,000/mm3; iv. Swelling and/or induration; erythema; v. Purulent or seropurulent drainage or discharge

  3. 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)
  4. Informed consent obtained and signed
  5. In patient hospitalization no more than 24 hours prior to randomization

Exclusion Criteria:

  1. Patients with known bacteremia, osteomyelitis, septic arthritis, or endocarditis
  2. Conditions where surgery (in and of itself) constitutes curative treatment of the infection (e.g., amputation, Incision &Drainage)
  3. cSSSIs which can be managed with an oral antibiotic
  4. Patients where hospitalization is expected to be <48hrs
  5. Nosocomial infection
  6. Patients with necrotizing infections or concomitant gangrene
  7. 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
  8. Pathogens identified at study entry to be nonsusceptible to daptomycin or vancomycin
  9. Patients with neutropenia or compromised immune function [i.e., severe neutropenia (absolute neutrophil count <500 cells/μL) or is anticipated to develop severe neutropenia during the study period due to prior or planned therapy]
  10. Renal insufficiency (calculated CLcr <30 mL/min or on dialysis)
  11. Known to be allergic or intolerant to daptomycin or vancomycin
  12. Pregnant or nursing mothers
  13. Suspected implanted device or prosthetic as source of infection
  14. Is considered unlikely to comply with study procedures or to be available for follow-up contact
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01419184

  Show 26 Study Locations
Sponsors and Collaborators
Cubist Pharmaceuticals
Investigators
Study Director: Cubist Pharmaceuticals Medical Monitor Cubist Pharmaceuticals
  More Information

No publications provided

Responsible Party: Cubist Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01419184     History of Changes
Other Study ID Numbers: DAP-HEOR-10-06
Study First Received: August 16, 2011
Last Updated: October 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Cubist Pharmaceuticals:
Complicated Skin and Skin Structure Infections (cSSSI)
Methicillin-resistant Staphylococcus aureus (MRSA)
Daptomycin
Vancomycin
Antibiotics

Additional relevant MeSH terms:
Skin Diseases, Infectious
Staphylococcal Skin Infections
Staphylococcal Infections
Infection
Skin Diseases
Gram-Positive Bacterial Infections
Bacterial Infections
Skin Diseases, Bacterial
Methicillin
Vancomycin
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014