Skin Diseases, InfectiousPhase 3NCT00228982
Ceftobiprole in the Treatment of Resistant Staphylococcus Aureus Skin and Skin Structure Infections
A Phase 3 study testing Ceftobiprole medocaril and Vancomycin in people with Skin Diseases, Infectious and Skin Diseases, Bacterial, run by Basilea Pharmaceutica.
Trial summary
The purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril versus a comparator in the treatment of patients with complicated skin and skin structure infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Diseases, Infectious, Skin Diseases, Bacterial, Staphylococcal Skin Infections
- What is being tested?
- Ceftobiprole medocaril and Vancomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 784 participants
- Where
- No sites listed yet
- Study dates
- Oct 2004to Dec 2005
- Phase
- Phase 3
- 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
- Diagnosis of an infection consistent with complicated skin and skin structure infections.
Who cannot join
- Known or suspected hypersensitivity to any study medication
- Any known or suspected condition or concurrent treatment contraindicated by the prescribing information
- Previous enrollment in this study
- Treatment with any investigational drug within 30 days before enrollment.
About this study
Official title: A Phase III, Randomized, Double-Blind Study of Ceftobiprole Versus Comparator in the Treatment of Complicated Skin and Skin Structure Infections
The purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril versus a comparator in the treatment of patients with complicated skin and skin structure infections.
Read the detailed description
Ceftobiprole medocaril is a cephalosporin antibiotic with anti-MRSA (Methicillin-Resistant Staphylococcus Aureus) activity. Ceftobiprole medocaril is not yet approved for the treatment of complicated skin and skin structure infections. This is a randomized, double-blind, multicenter study of ceftobiprole medocaril plus placebo versus a comparator to assess the effectiveness and safety of ceftobiprole medocaril in patients with complicated skin and skin structure infections. The patients will be randomized to ceftobiprole medocaril plus placebo or a comparator. The primary endpoint is the clinical cure rate of ceftobiprole medocaril at the test-of-cure visit. The patients will receive either ceftobiprole medocaril plus placebo or a comparator for 7 to 14 days (unless extended at discretion of medical monitor).
- Being tested
- Ceftobiprole medocaril, Vancomycin
- Keywords
- Complicated Skin Infections, Infectious Skin Diseases, Bacterial Skin Diseases, Staphylococcal Skin Infections, Cephalosporin
- Medical subject headings
- Skin Diseases, Infectious, Skin Diseases, Bacterial, Staphylococcal Skin Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceftobiprole medocarilDrug
VancomycinDrug
| Study group | Role | What they receive |
|---|---|---|
| Ceftobiprole medocaril | Experimental | Ceftobiprole medocaril 500mg q12h as 1h infusion, 7-14d Receives: Drug: Ceftobiprole medocaril |
| Vancomycin | Active comparator | Vancomycin 1g q12h as 1h infusion, 7-14d Receives: Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcome (cure, failure, not evaluable) at 7-14 days after the end of therapy.
Measured: 7 weeks
Secondary outcomes (1)
Microbiological outcome at 7-14 days after the end of therapy. Clinical and microbiological outcome at late follow-up visit. Evolution of signs and symptoms of disease. Time to clinical cure. Safety and tolerability evaluations during the study.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Diseases, InfectiousStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 784 participants (actual)
Sponsor and investigators
- Lead sponsor
- Basilea Pharmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00228982
- Sponsor's protocol ID
- CR005038
- Other IDs
- BAP00154
- Status last verified
- Jul 2012
- First submitted
- 27 Sep 2005
- Last updated
- 26 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-Blind Study of Ceftobiprole Versus Comparator in the Treatment of Complicated Skin and Skin Structure Infections
- ClinicalTrials.gov ID
- NCT00228982
- Acronym / sponsor ID
- CR005038
- Keywords
- Complicated Skin Infections, Infectious Skin Diseases, Bacterial Skin Diseases, Staphylococcal Skin Infections, Cephalosporin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 784 participants (actual)
- Lead sponsor
- Basilea PharmaceuticaIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 29 Sep 2005 (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.
The purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril versus a comparator in the treatment of patients with complicated skin and skin structure infections.
Detailed description
Ceftobiprole medocaril is a cephalosporin antibiotic with anti-MRSA (Methicillin-Resistant Staphylococcus Aureus) activity. Ceftobiprole medocaril is not yet approved for the treatment of complicated skin and skin structure infections. This is a randomized, double-blind, multicenter study of ceftobiprole medocaril plus placebo versus a comparator to assess the effectiveness and safety of ceftobiprole medocaril in patients with complicated skin and skin structure infections. The patients will be randomized to ceftobiprole medocaril plus placebo or a comparator. The primary endpoint is the clinical cure rate of ceftobiprole medocaril at the test-of-cure visit. The patients will receive either ceftobiprole medocaril plus placebo or a comparator for 7 to 14 days (unless extended at discretion of medical monitor).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ceftobiprole medocaril | Experimental | Drug: Ceftobiprole medocarilCeftobiprole medocaril 500mg q12h as 1h infusion, 7-14d |
| Vancomycin | Active comparator | Drug: VancomycinVancomycin 1g q12h as 1h infusion, 7-14d |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of an infection consistent with complicated skin and skin structure infections.
Key exclusion criteria (4 listed)
- Known or suspected hypersensitivity to any study medication
- Any known or suspected condition or concurrent treatment contraindicated by the prescribing information
- Previous enrollment in this study
- Treatment with any investigational drug within 30 days before enrollment.
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 |
|---|---|---|
| Ceftobiprole medocaril | Drug | Ceftobiprole medocaril |
| Vancomycin | Drug | Vancomycin |
Primary outcome
Clinical outcome (cure, failure, not evaluable) at 7-14 days after the end of therapy.
Time frame: 7 weeks
1 secondary outcome
Microbiological outcome at 7-14 days after the end of therapy. Clinical and microbiological outcome at late follow-up visit. Evolution of signs and symptoms of disease. Time to clinical cure. Safety and tolerability evaluations during the study.
Time frame: 7 weeks
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 26 Jul 2012.
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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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ceftobiprole medocaril and Vancomycin in people with Skin Diseases, Infectious and Skin Diseases, Bacterial, run by Basilea Pharmaceutica.
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 1 inclusion and 4 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 26 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?
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?
Clinical outcome (cure, failure, not evaluable) at 7-14 days after the end of therapy. (time frame: 7 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 26 Jul 2012.