NCT00295178

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2006

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 21, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 23, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2006

Completed
Last Updated

September 7, 2017

Status Verified

September 1, 2017

Enrollment Period

6 months

First QC Date

February 21, 2006

Last Update Submit

September 6, 2017

Conditions

Cellulitis

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

DaptomycinDRUG
VancomycinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joseph Still Research Foundation

Augusta, Georgia, 30909, United States

Location

Related Publications (1)

  • 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.

    PMID: 19222623DERIVED

MeSH Terms

Conditions

Cellulitis

Interventions

DaptomycinVancomycin

Condition Hierarchy (Ancestors)

Skin Diseases, InfectiousInfectionsSuppurationConnective Tissue DiseasesSkin and Connective Tissue DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsLipopeptidesLipidsPeptidesAmino Acids, Peptides, and ProteinsGlycopeptidesGlycoconjugatesCarbohydrates

Study Officials

  • Bruce Friedman, MD

    Joseph M. Still Research Foundation, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2006

First Posted

February 23, 2006

Study Start

February 20, 2006

Primary Completion

August 9, 2006

Study Completion

August 9, 2006

Last Updated

September 7, 2017

Record last verified: 2017-09

Locations

US(1)