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

Primary Purpose

Cellulitis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Daptomycin
Vancomycin
Sponsored by
Cubist Pharmaceuticals LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cellulitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Joseph Still Research Foundation

Outcomes

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

Full Information

First Posted
February 21, 2006
Last Updated
September 6, 2017
Sponsor
Cubist Pharmaceuticals LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00295178
Brief Title
Study Comparing CUBICIN® (Daptomycin for Injection) With Vancomycin in Cellulitis or Erysipelas
Official Title
A Multicenter, Randomized Study Comparing CUBICIN® (Daptomycin for Injection) With Vancomycin in the Treatment of Cellulitis or Erysipelas
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
February 20, 2006 (Actual)
Primary Completion Date
August 9, 2006 (Actual)
Study Completion Date
August 9, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cubist Pharmaceuticals LLC

4. Oversight

5. Study Description

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 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.
Detailed Description
same as above

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cellulitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
80 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Daptomycin
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Primary Outcome Measure Information:
Title
investigating the differences in speed and degree of symptom resolution between CUBICIN and vancomycin
Secondary Outcome Measure Information:
Title
frequency of Serious Adverse Events between daptomycin and vancomycin will be described

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Friedman, MD
Organizational Affiliation
Joseph M. Still Research Foundation, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Joseph Still Research Foundation
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19222623
Citation
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. doi: 10.1111/j.1742-1241.2008.01988.x.
Results Reference
derived

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

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