CellulitisPhase 4NCT00295178
Study Comparing CUBICIN® (Daptomycin for Injection) With Vancomycin in Cellulitis or Erysipelas
A Phase 4 study testing Daptomycin and Vancomycin in people with Cellulitis, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cellulitis
- What is being tested?
- Daptomycin and Vancomycin
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2006to 9 Aug 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Joseph Still Research Foundation
Augusta, Georgia, 30909
About this study
Official title: 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.
Read the detailed description
same as above
- Conditions
- Cellulitis
- Being tested
- Daptomycin, Vancomycin
- Medical subject headings
- Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaptomycinDrug
VancomycinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2006 (estimated)
- Study start20 Feb 2006
- Primary completion9 Aug 2006
- Study completion9 Aug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CellulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruce Friedman, MD, Principal investigator, Joseph M. Still Research Foundation, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00295178
- Sponsor's protocol ID
- 3009-008
- Other IDs
- DAP-4CELL-05-02
- Status last verified
- Sep 2017
- First submitted
- 21 Feb 2006
- Last updated
- 7 Sep 2017
- Results posted
- No
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.
PubMed 19222623
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Study Comparing CUBICIN® (Daptomycin for Injection) With Vancomycin in the Treatment of Cellulitis or Erysipelas
- ClinicalTrials.gov ID
- NCT00295178
- Acronym / sponsor ID
- 3009-008
- Conditions
- Cellulitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Study start
- 20 Feb 2006 (actual)
- Primary completion
- 9 Aug 2006 (actual)
- Study completion
- 9 Aug 2006 (actual)
- First posted
- 23 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daptomycin | Drug | – |
| Vancomycin | Drug | – |
Primary outcome
investigating the differences in speed and degree of symptom resolution between CUBICIN and vancomycin
1 secondary outcome
frequency of Serious Adverse Events between daptomycin and vancomycin will be described
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2017.
- Derived from this study: PubMed 19222623Pertel 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.
Related trials for Cellulitis
Not yet recruitingPhase 4
A Single Dose of Intravenous Penicillin as an Adjunct to Oral Penicillin in the Treatment of Acute Tonsillitis, Peritonsillar Phlegmon, and Peritonsillar Abscess
Acute Tonsillitis, Peritonsillar Abscess
Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruitingPhase 3
Naproxen Versus Placebo as Adjunct Treatment of Cellulitis
Cellulitis, Skin Disease, Infectious
Not yet recruiting
Moxifloxacin Versus Clindamycin in the Management of Odontogenic Maxillofacial Infectious Processes
Odontogenic Infection, Maxillofacial Infection
Recruiting
Perspectives on Antibiotics and Tracking Symptoms in Children
Urinary Tract Infection, Cellulitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Friedman, MD principal investigator
Joseph M. Still Research Foundation, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Daptomycin and Vancomycin in people with Cellulitis, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
investigating the differences in speed and degree of symptom resolution between CUBICIN and vancomycin. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00295178, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2017.