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

February 21, 2006
December 14, 2006
March 2006
 
investigating the differences in speed and degree of symptom resolution between CUBICIN and vancomycin
Same as current
Complete list of historical versions of study NCT00295178 on ClinicalTrials.gov Archive Site
frequency of Serious Adverse Events between daptomycin and vancomycin will be described
Same as current
 
Study Comparing CUBICIN® (Daptomycin for Injection) With Vancomycin in Cellulitis or Erysipelas
A Multicenter, Randomized Study Comparing CUBICIN® (Daptomycin for Injection) With Vancomycin in the Treatment of Cellulitis or Erysipelas

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.

same as above

Phase IV
Interventional
Treatment, Randomized, Single Blind, Active Control, Parallel Assignment
Cellulitis
  • Drug: Daptomycin
  • Drug: Vancomycin
 
Pertel PE, Eisenstein BI, Link AS, Donfrid B, Biermann EJ, Bernardo P, Martone WJ. The efficacy and safety of daptomycin vs. vancomycin for the treatment of cellulitis and erysipelas. Int J Clin Pract. 2009 Mar;63(3):368-75.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
80
August 2006
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00295178
 
DAP-4CELL-05-02
Cubist Pharmaceuticals
 
Principal Investigator: Bruce Friedman, MD Joseph M. Still Research Foundation, Inc.
Cubist Pharmaceuticals
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP