Status:
COMPLETED
Study Comparing CUBICIN® (Daptomycin for Injection) With Vancomycin in Cellulitis or Erysipelas
Lead Sponsor:
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Cellulitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 f...
Detailed Description
same as above
Eligibility Criteria
Inclusion
- Read and sign the informed consent form after the nature of the study has been fully explained;
- Male or female \> or = 18 years of age;
- If female of childbearing potential, a negative pregnancy test is required;
- Primary diagnosis of cellulitis/ erysipelas
- with onset of signs or symptoms within 3 days of 1st dose of study medication
- requiring hospitalization, and severe enough to warrant IV antibiotics
- temperature \>37.5°C (99.5° F) oral or \>38° C (100.2° F) rectal, documented within 48 hours prior to enrollment, and
- anticipated treatment to be limited to medical (NOT surgical) interventions
- at an anatomical location that allows of a clear assessment of the erythema margin
Exclusion
- Pregnant or lactating female;
- Conditions where required surgery (in and of itself) constitutes curative treatment of the infection or removal of infected site (e.g., amputation);
- Conditions requiring emergent surgical intervention at the site of infection (e.g., progressive necrotizing infections);
- 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;
- Cellulitis associated with a wound infection or ulcer requiring incision and drainage or debridement
- Perirectal abscess or hidradenitis suppurativa or third degree burn infections
- Buccal cellulitis, facial cellulitis, perianal cellulitis, or periorbital cellulitis;
- Known or suspected osteomyelitis, pneumonia, bacteremia, endocarditis, or urinary tract infection;
- Known to be allergic or intolerant to study medications;
- Subjects with a Creatinine Clearance (CLCR) \<30 mL/min;
- Requirement for non-study systemic antibiotics;
- Requirement for systemic steroids from enrollment through stabilization of cellulitis;
- Rhabdomyolysis;
- Neutropenic subjects with absolute neutrophil count ≤ 500 cells/mm3
Key Trial Info
Start Date :
February 20 2006
Trial Type :
INTERVENTIONAL
End Date :
August 9 2006
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00295178
Start Date
February 20 2006
End Date
August 9 2006
Last Update
September 7 2017
Active Locations (1)
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1
Joseph Still Research Foundation
Augusta, Georgia, United States, 30909