Skin Diseases, InfectiousPhase 3NCT00210899
Ceftobiprole in the Treatment of Resistant Staphylococcus Aureus Skin and Skin Structure Infections
A Phase 3 study testing ceftobiprole medocaril and Vancomycin plus Ceftazidime 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 plus Ceftazidime
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 828 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Oct 2006
- 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 or other related anti-infective 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. The study will also characterize the safety and tolerability of treatment with ceftobiprole medocaril in 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 patients can be treated as in-patient, out-patient, or through a home agency, at the discretion of the investigator. 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 plus Ceftazidime
- 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
Vancomycin plus CeftazidimeDrug
| Study group | Role | What they receive |
|---|---|---|
| Vancomycin plus Ceftazidime | Active comparator | Vancomycin 1g q12h as 1h infusions plus Ceftazidime 1g q8h in 2h-infusions, 7-14d Receives: Drug: Vancomycin plus Ceftazidime |
| Ceftobiprole medocaril | Experimental | Ceftobiprole medocaril 500mg q8h as 2h infusions, 7-14d Receives: Drug: ceftobiprole medocaril |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure rate (the ratio of the number of clinically cured patients to the total number of patients in the population) at 7-14 days after the end of therapy.
7-14 days treatment, test of cure assessment at 7-14 days after end of treatment, late follow-up 28-35 days after end of treatment
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 posted21 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionOct 2006
- Study completionOct 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 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
- 828 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
- NCT00210899
- Sponsor's protocol ID
- CR005029
- Other IDs
- BAP00414
- Status last verified
- Jul 2012
- First submitted
- 13 Sep 2005
- Last updated
- 26 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Noel GJ, Bush K, Bagchi P, Ianus J, Strauss RS. A randomized, double-blind trial comparing ceftobiprole medocaril with vancomycin plus ceftazidime for the treatment of patients with complicated skin and skin-structure infections. Clin Infect Dis. 2008 Mar 1;46(5):647-55. doi: 10.1086/526527.
PubMed 18225981
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
- NCT00210899
- Acronym / sponsor ID
- CR005029
- Keywords
- Complicated Skin Infections, Infectious Skin Diseases, Bacterial Skin Diseases, Staphylococcal Skin Infections, Cephalosporin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 828 participants (actual)
- Lead sponsor
- Basilea PharmaceuticaIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 21 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. The study will also characterize the safety and tolerability of treatment with ceftobiprole medocaril in 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 patients can be treated as in-patient, out-patient, or through a home agency, at the discretion of the investigator. 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 |
|---|---|---|
| Vancomycin plus Ceftazidime | Active comparator | Drug: Vancomycin plus CeftazidimeVancomycin 1g q12h as 1h infusions plus Ceftazidime 1g q8h in 2h-infusions, 7-14d |
| Ceftobiprole medocaril | Experimental | Drug: ceftobiprole medocarilCeftobiprole medocaril 500mg q8h as 2h infusions, 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 or other related anti-infective 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 plus Ceftazidime | Drug | Vancomycin plus Ceftazidime |
Primary outcome
Clinical cure rate (the ratio of the number of clinically cured patients to the total number of patients in the population) at 7-14 days after the end of therapy.
Time frame: 7 weeks
7-14 days treatment, test of cure assessment at 7-14 days after end of treatment, late follow-up 28-35 days after end of treatment
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.
- Results publication: PubMed 18225981Noel GJ, Bush K, Bagchi P, Ianus J, Strauss RS. A randomized, double-blind trial comparing ceftobiprole medocaril with vancomycin plus ceftazidime for the treatment of patients with complicated skin and skin-structure infections. Clin Infect Dis. 2008 Mar 1;46(5):647-55. doi: 10.1086/526527.
- Ceftobiprole in the Treatment of Resistant Staphylococcus Aureus Skin and Skin Structure InfectionsLink provided by the sponsor.
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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 plus Ceftazidime 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 cure rate (the ratio of the number of clinically cured patients to the total number of patients in the population) 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?
On the ClinicalTrials.gov record for NCT00210899, 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 26 Jul 2012.