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Study Comparing CUBICIN® (Daptomycin for Injection) With Vancomycin in Cellulitis or Erysipelas
This study has been completed.
First Received: February 21, 2006   Last Updated: December 14, 2006   History of Changes
Sponsored by: Cubist Pharmaceuticals
Information provided by: Cubist Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00295178
  Purpose

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 Intervention Phase
Cellulitis
Drug: Daptomycin
Drug: Vancomycin
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment
Official Title: A Multicenter, Randomized Study Comparing CUBICIN® (Daptomycin for Injection) With Vancomycin in the Treatment of Cellulitis or Erysipelas

Resource links provided by NLM:


Further study details as provided by Cubist Pharmaceuticals:

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

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

Estimated Enrollment: 80
Study Start Date: March 2006
Estimated Study Completion Date: August 2006
Detailed Description:

same as above

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00295178

Locations
United States, Georgia
Joseph Still Research Foundation
Augusta, Georgia, United States, 30909
Sponsors and Collaborators
Cubist Pharmaceuticals
Investigators
Principal Investigator: Bruce Friedman, MD Joseph M. Still Research Foundation, Inc.
  More Information

No publications provided by Cubist Pharmaceuticals

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Study ID Numbers: DAP-4CELL-05-02
Study First Received: February 21, 2006
Last Updated: December 14, 2006
ClinicalTrials.gov Identifier: NCT00295178     History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Bacterial Infections
Skin Diseases
Inflammation
Daptomycin
Anti-Bacterial Agents
Cellulitis
Skin Diseases, Infectious
Gram-Positive Bacterial Infections
Streptococcal Infections
Skin Diseases, Bacterial
Connective Tissue Diseases
Erysipelas
Suppuration
Vancomycin

Additional relevant MeSH terms:
Bacterial Infections
Anti-Infective Agents
Skin Diseases
Infection
Pharmacologic Actions
Inflammation
Daptomycin
Anti-Bacterial Agents
Cellulitis
Skin Diseases, Infectious
Gram-Positive Bacterial Infections
Pathologic Processes
Streptococcal Infections
Therapeutic Uses
Skin Diseases, Bacterial
Connective Tissue Diseases
Vancomycin
Erysipelas
Suppuration

ClinicalTrials.gov processed this record on July 02, 2009