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

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

• Status: Completed
• Conditions: Cellulitis
• Intervention / Treatment: Drug: Vancomycin; Drug: Daptomycin

Detailed Description

same as above

• Study Type: Interventional
• Enrollment: 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Joseph Still Research Foundation

Participation Criteria

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:

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

Study Plan

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cubist Pharmaceuticals LLC
• Investigators: Principal Investigator: Bruce Friedman, MD, Joseph M. Still Research Foundation, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

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)