Skin Diseases, InfectiousPhase 3NCT00430937
Efficacy and Safety of Daptomycin Versus Vancomycin or Teicoplanin for Treatment of Complicated Skin and Soft Tissue Infections
A Phase 3 study testing Daptomycin, Vancomycin and Teicoplanin in people with Skin Diseases, Infectious and Soft Tissue Infections, run by Novartis Pharmaceuticals.
Trial summary
This study evaluated the efficacy and safety of daptomycin compared to vancomycin or teicoplanin for the treatment of complicated skin and soft tissue infections Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Diseases, Infectious, Soft Tissue Infections
- What is being tested?
- Daptomycin, Vancomycin and Teicoplanin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to Mar 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subjects with a diagnosis of cSSTI
- Infection known or suspected (based on Gram's stain) to be due, at least partially, to Gram-positive bacteria.
- Hospitalised subjects with clinical evidence of at least one of the following:I infected ulcers , major abscess. deep or extensive cellulitis, post-surgical / post-traumatic wound infection
- Presence of at least two of the following: drainage and/or discharge from the infection site, redness, swelling and/or hardened skin, heat and/or localised warmth, pain and/or tenderness to touch, presence of pus.
Who cannot join
- cSSTIs of the following categories:
- Infected burns,
- Severely impaired arterial blood supply (such that the likelihood of amputation of the infected anatomical site is likely),
- Decubitus ulcers,
- Infected diabetic foot ulcers associated with osteomyelitis,
- Infected human or animal bites, superficial infections or abscesses in an anatomic site, such as the rectal area, where the risk of anaerobic or Gram-negative pathogen involvement is high (e.g. perirectal abscess),
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- Necrotising fasciitis or gangrene,
- cSSTI expected to require more than 14 days of intravenous antimicrobial therapy,
- Skin and/or skin structure infection that can be treated by surgery alone,
- Infections associated with a permanent prosthetic device that will not be removed within 2 days of study randomisation
- Subjects with documented bacteraemia at Baseline or those with shock or hypotension
- Concomitant clinically suspected or confirmed other site of infection or disorder at study entry that may interfere with the evaluations in this protocol
- Treatment with vancomycin or teicoplanin within the past 48 hours, unless administered for less than 24 hours.
- Subjects admitted to the hospital for conditions associated with rhabdomyolysis or those with an infection due to an organism known prior to study entry to be resistant to daptomycin, vancomycin or teicoplanin.
- Previously diagnosed disease of immune function. Human Immunodeficiency Virus (HIV) infected subjects without Acquired Immune Deficiency Syndrome (AIDS) may be enrolled.
- Subjects receiving oral steroids or receiving immunosuppressant drugs after organ transplant.
- Absence of purulent material for initial culture and Gram's stain. Subjects with cellulitis may be enrolled in the absence of purulent material, provided that infection with a Gram-positive organism is suspected.
- Subjects who have received more than 48 hours of any systemic antibiotic or topical antibiotic at the infection site with activity against Gram-positive pathogens, unless there is clinical evidence of treatment failure OR documented resistance in the identified Gram-positive pathogen to the previous antibiotic therapy.
- cSSTI suspected or documented as being due exclusively to Gram-negative or anaerobic organisms based on epidemiology or on direct examination of a Gram-stained specimen.
- Subjects diagnosed with pneumonia or those with severe renal impairment or hepatic disease
- Previous history of hearing loss. Other protocol defined inclusion/exclusion criteria may apply.
About this study
Official title: A Multicenter, Randomized, Assessor-Blind Study to Evaluate Efficacy and Safety of Daptomycin Versus Vancomycin or Teicoplanin for Treatment of Complicated Skin and Soft Tissue Infections (cSSTI)
This study evaluated the efficacy and safety of daptomycin compared to vancomycin or teicoplanin for the treatment of complicated skin and soft tissue infections
- Conditions
- Skin Diseases, Infectious, Soft Tissue Infections
- Being tested
- Daptomycin, Vancomycin, Teicoplanin
- Keywords
- Complicated Skin and Soft Tissue Infections. Daptomycin, Vancomycin, Teicoplanin, Complicated skin and soft tissue infections
- Medical subject headings
- Skin Diseases, Infectious, Soft Tissue Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaptomycinDrug
Also called Cubicin
4 mg/kg intravenous once daily
VancomycinDrug
Also called Vancocin
1 g intravenous twice daily
TeicoplaninDrug
Also called Targocid
400 mg intravenous once daily following a loading dose of 400 mg administered at 0, 12, 24 hours on day one.
| Study group | Role | What they receive |
|---|---|---|
| Daptomycin | Experimental | 4 mg/kg intravenous (i.v.) once daily Receives: Drug: Daptomycin |
| Pooled Comparator | Active comparator | Not described Receives: Drug: Vancomycin; Drug: Teicoplanin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success as Measured by Comparing the Participants Signs and Symptoms at the "Test of Cure" (TOC) Visit to Those Recorded at Study Baseline in the Clinically Evaluable Population.
Success: Total resolution of clinically significant signs and symptoms of the infection site (cure) or improvement to such a level that no further antibacterial therapy was required (improvement).
Failure: Persistence or progression of signs and symptoms after at least 3 days of study therapy, or development of new signs and symptoms at the infection site, or concomitant or additional antibacterial therapy with documented activity against isolated organisms, or a treatment duration greater than 14 days, or requirement of a major surgical procedure as adjunct or follow-up therapy.
Measured: Baseline to TOC Visit (7-14 days after end of treatment) up to 4 weeks
Secondary outcomes (1)
Microbiological Efficacy Measured by the Number of Participants Achieving Bacteriological Eradication of Gram-positive Baseline Pathogens at the TOC Visit.
Microbiological Success: All infecting Gram-positive pathogens isolated at baseline were eradicated at the TOC evaluation and a superinfecting pathogen was not isolated either prior to or at the TOC evaluation.
Microbiological Failure: Persistence of one or more infecting Gram-positive pathogens or isolation of a superinfecting pathogen prior to or at the TOC evaluation.
Measured: Baseline to TOC Visit (7-14 days after end of treatment) up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2007 (estimated)
- Study startApr 2006
- Primary completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Skin Diseases, InfectiousStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00430937
- Sponsor's protocol ID
- CCBC134A2402
- Status last verified
- Jul 2012
- First submitted
- 1 Feb 2007
- Last updated
- 16 Jul 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Assessor-Blind Study to Evaluate Efficacy and Safety of Daptomycin Versus Vancomycin or Teicoplanin for Treatment of Complicated Skin and Soft Tissue Infections (cSSTI)
- ClinicalTrials.gov ID
- NCT00430937
- Acronym / sponsor ID
- CCBC134A2402
- Conditions
- Skin Diseases, Infectious, Soft Tissue Infections
- Keywords
- Complicated Skin and Soft Tissue Infections. Daptomycin, Vancomycin, Teicoplanin, Complicated skin and soft tissue infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Mar 2008 (actual)
- First posted
- 2 Feb 2007 (estimated)
- Results
- Posted 5 Jan 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluated the efficacy and safety of daptomycin compared to vancomycin or teicoplanin for the treatment of complicated skin and soft tissue infections
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daptomycin | Experimental | Drug: Daptomycin4 mg/kg intravenous (i.v.) once daily |
| Pooled Comparator | Active comparator | Drug: Vancomycin, Drug: Teicoplanin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with a diagnosis of cSSTI
- Infection known or suspected (based on Gram's stain) to be due, at least partially, to Gram-positive bacteria.
- Hospitalised subjects with clinical evidence of at least one of the following:I infected ulcers , major abscess. deep or extensive cellulitis, post-surgical / post-traumatic wound infection
- Presence of at least two of the following: drainage and/or discharge from the infection site, redness, swelling and/or hardened skin, heat and/or localised warmth, pain and/or tenderness to touch, presence of pus.
Key exclusion criteria (21 listed)
- cSSTIs of the following categories:
- Subjects with documented bacteraemia at Baseline or those with shock or hypotension
- Concomitant clinically suspected or confirmed other site of infection or disorder at study entry that may interfere with the evaluations in this protocol
- Treatment with vancomycin or teicoplanin within the past 48 hours, unless administered for less than 24 hours.
- Subjects admitted to the hospital for conditions associated with rhabdomyolysis or those with an infection due to an organism known prior to study entry to be resistant to daptomycin, vancomycin or teicoplanin.
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 |
|---|---|---|
| DaptomycinAlso: Cubicin4 mg/kg intravenous once daily | Drug | Daptomycin |
| VancomycinAlso: Vancocin1 g intravenous twice daily | Drug | Pooled Comparator |
| TeicoplaninAlso: Targocid400 mg intravenous once daily following a loading dose of 400 mg administered at 0, 12, 24 hours on day one. | Drug | Pooled Comparator |
Primary outcome
Clinical Success as Measured by Comparing the Participants Signs and Symptoms at the "Test of Cure" (TOC) Visit to Those Recorded at Study Baseline in the Clinically Evaluable Population.
Time frame: Baseline to TOC Visit (7-14 days after end of treatment) up to 4 weeks
Success: Total resolution of clinically significant signs and symptoms of the infection site (cure) or improvement to such a level that no further antibacterial therapy was required (improvement). Failure: Persistence or progression of signs and symptoms after at least 3 days of study therapy, or development of new signs and symptoms at the infection site, or concomitant or additional antibacterial therapy with documented activity against isolated organisms, or a treatment duration greater than 14 days, or requirement of a major surgical procedure as adjunct or follow-up therapy.
1 secondary outcome
Microbiological Efficacy Measured by the Number of Participants Achieving Bacteriological Eradication of Gram-positive Baseline Pathogens at the TOC Visit.
Time frame: Baseline to TOC Visit (7-14 days after end of treatment) up to 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Novartis Pharmaceuticals study director
Novartis
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Daptomycin, Vancomycin and Teicoplanin in people with Skin Diseases, Infectious and Soft Tissue Infections, run by Novartis Pharmaceuticals.
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 4 inclusion and 21 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: stopped early, as of the sponsor's last update on 16 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clinical Success as Measured by Comparing the Participants Signs and Symptoms at the "Test of Cure" (TOC) Visit to Those Recorded at Study Baseline in the Clinically Evaluable Population. (time frame: Baseline to TOC Visit (7-14 days after end of treatment) up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2012.