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

This study has been completed.
Sponsor:
Information provided by:
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00295178
First received: February 21, 2006
Last updated: December 14, 2006
Last verified: December 2006
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
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
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, see Learn About Clinical Studies.

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 ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00295178     History of Changes
Other Study ID Numbers: DAP-4CELL-05-02
Study First Received: February 21, 2006
Last Updated: December 14, 2006
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 27, 2014