Study Comparing CUBICIN® (Daptomycin for Injection) With Vancomycin in Cellulitis or Erysipelas
This study has been completed.
Sponsor:
Cubist Pharmaceuticals
Information provided by:
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00295178
First received: February 21, 2006
Last updated: December 14, 2006
Last verified: December 2006
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
same as above
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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 Skin Diseases, Infectious Infection Suppuration Connective Tissue Diseases Inflammation Pathologic Processes Streptococcal Infections Gram-Positive Bacterial Infections |
Bacterial Infections Skin Diseases, Bacterial Skin Diseases Vancomycin Daptomycin Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013