- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00295178
Study Comparing CUBICIN® (Daptomycin for Injection) With Vancomycin in Cellulitis or Erysipelas
September 6, 2017 updated by: Cubist Pharmaceuticals LLC
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.
Study Overview
Detailed Description
same as above
Study Type
Interventional
Enrollment
80
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Georgia
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Augusta, Georgia, United States, 30909
- Joseph Still Research Foundation
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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investigating the differences in speed and degree of symptom resolution between CUBICIN and vancomycin
|
Secondary Outcome Measures
Outcome Measure |
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frequency of Serious Adverse Events between daptomycin and vancomycin will be described
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bruce Friedman, MD, Joseph M. Still Research Foundation, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 20, 2006
Primary Completion (ACTUAL)
August 9, 2006
Study Completion (ACTUAL)
August 9, 2006
Study Registration Dates
First Submitted
February 21, 2006
First Submitted That Met QC Criteria
February 21, 2006
First Posted (ESTIMATE)
February 23, 2006
Study Record Updates
Last Update Posted (ACTUAL)
September 7, 2017
Last Update Submitted That Met QC Criteria
September 6, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Skin Diseases
- Infections
- Inflammation
- Connective Tissue Diseases
- Bacterial Infections
- Bacterial Infections and Mycoses
- Streptococcal Infections
- Gram-Positive Bacterial Infections
- Skin Diseases, Infectious
- Suppuration
- Skin Diseases, Bacterial
- Cellulitis
- Erysipelas
- Anti-Infective Agents
- Anti-Bacterial Agents
- Vancomycin
- Daptomycin
Other Study ID Numbers
- 3009-008
- DAP-4CELL-05-02 (OTHER: Cubist)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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