Study Comparing CUBICIN® (Daptomycin for Injection) With Vancomycin in Cellulitis or Erysipelas (NCT00295178) | Clinical Trial Compass
CompletedPhase 4
Study Comparing CUBICIN® (Daptomycin for Injection) With Vancomycin in Cellulitis or Erysipelas
United States80 participantsStarted 2006-02-20
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
investigating the differences in speed and degree of symptom resolution between CUBICIN and vancomycin
Trial details
NCT IDNCT00295178
SponsorCubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
. anticipated treatment to be limited to medical (NOT surgical) interventions
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;