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

ID: NCT00295178
Status: Completed
Phase: Phase 4
Start Date: February 20, 2006
First Submitted: February 21, 2006
Last Updated: September 06, 2017
Results: N/A
Sponsors & Collaborators: Cubist Pharmaceuticals LLC
Location: United States
Conditions: Cellulitis
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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
Condition or disease Intervention/treatment Phase

Cellulitis

Drug: Daptomycin
Other Names
Drug: Vancomycin
Other Names
Phase 4

Tracking Information

First Submitted DateFebruary 21, 2006
Last Update Posted DateSeptember 06, 2017
Actual Start DateFebruary 20, 2006
Actual Completion DateAugust 09, 2006
Actual Primary Completion DateAugust 09, 2006
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • investigating the differences in speed and degree of symptom resolution between CUBICIN and vancomycin

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • frequency of Serious Adverse Events between daptomycin and vancomycin will be described

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleStudy Comparing CUBICIN® (Daptomycin for Injection) With Vancomycin in Cellulitis or Erysipelas
Official TitleA Multicenter, Randomized Study Comparing CUBICIN® (Daptomycin for Injection) With Vancomycin in the Treatment of Cellulitis or Erysipelas
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

Study TypeInterventional
Study PhasePhase 4
Estimated Enrollment
80
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Single
Primary Purpose
Treatment
Conditions
Cellulitis
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: Daptomycin

Other Names
Drug: Vancomycin

Other Names
Study Groups/Cohorts
Not Available
Study Arms
Not Available
Arm Intervention/Treatment

Recruitment Information

Recruitment Status:Completed
Enrollment80
Completion DateAugust 09, 2006
Eligibility Criteria: 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
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
United States

Administrative Information

NCT Number:NCT00295178
Other Study ID Numbers
3009-008
DAP-4CELL-05-02
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Cubist Pharmaceuticals LLC
Collaborators
Not Available
Investigators
Principal Investigator
Bruce Friedman, MD
Joseph M. Still Research Foundation, Inc.