Working… Menu

Study Comparing CUBICIN® (Daptomycin for Injection) With Vancomycin in Cellulitis or Erysipelas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00295178
Recruitment Status : Completed
First Posted : February 23, 2006
Last Update Posted : September 7, 2017
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC

Brief Summary:

This study is designed to investigate the difference in speed and degree of symptom resolution between daptomycin and vancomycin in subjects treated for cellulitis or erysipelas by evaluation of the following parameters:

  • Time to erythema margin cessation to progress
  • Time to defervescence
  • Time to hospital discharge following relief of the presenting cellulitis or erysipelas
  • Degree of improvement of the following signs and symptom of cellulitis or erysipelas including
  • Degree of improvement of cellulitis-related pain and swelling as reported by subjects

Additionally, the difference in frequency of Adverse Events between daptomycin and vancomycin will be described.

Condition or disease Intervention/treatment Phase
Cellulitis Drug: Daptomycin Drug: Vancomycin Phase 4

Detailed Description:
same as above

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized Study Comparing CUBICIN® (Daptomycin for Injection) With Vancomycin in the Treatment of Cellulitis or Erysipelas
Actual Study Start Date : February 20, 2006
Actual Primary Completion Date : August 9, 2006
Actual Study Completion Date : August 9, 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cellulitis

Primary Outcome Measures :
  1. investigating the differences in speed and degree of symptom resolution between CUBICIN and vancomycin

Secondary Outcome Measures :
  1. frequency of Serious Adverse Events between daptomycin and vancomycin will be described

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Read and sign the informed consent form after the nature of the study has been fully explained;
  2. Male or female > or = 18 years of age;
  3. If female of childbearing potential, a negative pregnancy test is required;
  4. Primary diagnosis of cellulitis/ erysipelas

    1. with onset of signs or symptoms within 3 days of 1st dose of study medication
    2. requiring hospitalization, and severe enough to warrant IV antibiotics
    3. temperature >37.5°C (99.5° F) oral or >38° C (100.2° F) rectal, documented within 48 hours prior to enrollment, and
    4. anticipated treatment to be limited to medical (NOT surgical) interventions
    5. at an anatomical location that allows of a clear assessment of the erythema margin

Exclusion Criteria:

  1. Pregnant or lactating female;
  2. Conditions where required surgery (in and of itself) constitutes curative treatment of the infection or removal of infected site (e.g., amputation);
  3. Conditions requiring emergent surgical intervention at the site of infection (e.g., progressive necrotizing infections);
  4. Previous systemic antimicrobial therapy exceeding 24 hours duration, administered anytime during the 72 hours prior to the first dose of study drug unless on previous antibiotics for at least 72 hours and without any clinical improvement;
  5. Cellulitis associated with a wound infection or ulcer requiring incision and drainage or debridement
  6. Perirectal abscess or hidradenitis suppurativa or third degree burn infections
  7. Buccal cellulitis, facial cellulitis, perianal cellulitis, or periorbital cellulitis;
  8. Known or suspected osteomyelitis, pneumonia, bacteremia, endocarditis, or urinary tract infection;
  9. Known to be allergic or intolerant to study medications;
  10. Subjects with a Creatinine Clearance (CLCR) <30 mL/min;
  11. Requirement for non-study systemic antibiotics;
  12. Requirement for systemic steroids from enrollment through stabilization of cellulitis;
  13. Rhabdomyolysis;
  14. Neutropenic subjects with absolute neutrophil count ≤ 500 cells/mm3

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00295178

Layout table for location information
United States, Georgia
Joseph Still Research Foundation
Augusta, Georgia, United States, 30909
Sponsors and Collaborators
Cubist Pharmaceuticals LLC
Layout table for investigator information
Principal Investigator: Bruce Friedman, MD Joseph M. Still Research Foundation, Inc.
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Cubist Pharmaceuticals LLC Identifier: NCT00295178    
Other Study ID Numbers: 3009-008
DAP-4CELL-05-02 ( Other Identifier: Cubist )
First Posted: February 23, 2006    Key Record Dates
Last Update Posted: September 7, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Skin Diseases, Infectious
Connective Tissue Diseases
Pathologic Processes
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Skin Diseases, Bacterial
Skin Diseases
Anti-Bacterial Agents
Anti-Infective Agents