Bacterial InfectionsPhase 3cSSSINCT00424190
Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections
A Phase 3 study testing IV Vancomycin plus IV Aztreonam and Ceftaroline in people with Bacterial Infections, run by Forest Laboratories at 52 sites in 11 countries.
Trial summary
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- IV Vancomycin plus IV Aztreonam and Ceftaroline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 698 participants
- Where
- 52 sitesin 11 countries
- Study dates
- Feb 2007to Nov 2007
- 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
- Skin and skin structure infection (SSSI) that involves deeper soft tissue or requires significant surgical intervention, or cellulitis or abscess on lower extremity which occurs in subjects with diabetes mellitus or well-documented peripheral vascular disease.
Who cannot join
- Prior treatment of current cSSSI with an antimicrobial.
- Failure of vancomycin or aztreonam as therapy for the current cSSSI, or prior isolation of an organism with in vitro resistance to vancomycin or aztreonam.
Trial locations and contacts
52 sites in 11 countries.
52 sites in 11 countries
United States15 sites
Investigational Site
Columbus, Ohio, 43215
Investigational Site
Dothan, Alabama, 36301
Investigational Site
Indianapolis, Indiana, 46280
Investigational Site
Landsdale, Pennsylvania, 19446
Investigational Site
Long Beach, California, 90813
Investigational Site
Los Angeles, California, 90015
Investigational Site
Naperville, Illinois, 60540
Investigational Site
Sacramento, California, 95817
Investigational Site
Sacramento, California, 95819
Investigational Site
San Diego, California, 92114
Investigational Site
San Francisco, California, 94110
Investigational Site
Savannah, Georgia, 31405
Investigational Site
Shreveport, Louisiana, 71103
Investigational Site
Tacoma, Washington, 98405
Investigational Site
Torrance, California, 90509
Argentina8 sites
Investigational Site
Buenos Aires, 1240 C1180AAX
Investigational Site
Buenos Aires, 164
Investigational Site
Buenos Aires
Invetigational Site
Buenos Aires
Investigational Site
Córdoba
Invetigational Site
Córdoba
Investigational Site
Entre Ríos
Investigational Site
Santa Fe
Russia7 sites
Investigational Site
Moscow, 105229
Investigational Site
Moscow, 111539
Investigational Site
Moscow, 129327
Investigational Site
Saint Petersburg, 192242
Investigational Site
Saint Petersburg, 194354
Investigational Site
Saint Petersburg, 196247
Investigational Site
Smolensk, 214019
Germany5 sites
Investigational Site
Berlin, D-10249
Investigational Site
Bochum, 44791
Investigational Site
Hanau
Investigational Site
Plauen, 08529
Investigational Site
Quedlinburg, 06484
Poland5 sites
Investigational Site
Bytom, 41-902
Investigational Site
Krakow, 31-913
Investigational Site
Lublin, 20-081
Investigational Site
Sosnowiec, 41-200
Investigational Site
Todz, 91-425
Romania3 sites
Investigational Site
Bucharest, 010816
Investigational Site
Bucharest, 041915
Investigational Site
Timișoara, 300736
Ukraine3 sites
Investigational Site
Dnipropetrovsk, 49600
Investigational Site
Ivano-Frankivsk, 76008
Investigational Site
Lviv, 79659
Brazil2 sites
Investigational Site
Curiuba-Parans, 1089
Investigational Site
São Paulo, 04039-020
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline Versus Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin and Skin Structure Infection
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.
Read the detailed description
Additional purpose of the study is to compare ceftaroline effectivity versus Vancomycin plus Aztreonam in the treatment of complicated skin infections in adults.
- Conditions
- Bacterial Infections
- Being tested
- IV Vancomycin plus IV Aztreonam, Ceftaroline
- Keywords
- Abscess, Antibacterial, Antibiotic, Antimicrobial, Bacterial infection, skin, Ceftaroline, Ceftaroline acetate, Cellulitis, Cephalosporin, Complicated skin and skin structure infection, cSSSI, Intravenous, Methicillin-resistant Staphylococcus Aureus (MRSA), PPI-0903, Prodrug, Skin disease, bacterial, Skin infection, Staphylococcal skin infection, Staphylococcus aureus, Streptococcal skin infection
- Medical subject headings
- Bacterial Infections, Abscess, Skin Diseases, Bacterial, Cellulitis, Staphylococcal Skin Infections, Staphylococcal Infections, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV Vancomycin plus IV AztreonamDrug
Also called Active Comparator
vancomycin at 1 g parenteral infused over 60 minutes followed by aztreonam 1 g infused over 60 minutes, every 12 hours, for 5 to 14 days.
CeftarolineDrug
Also called Experimental
600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days
| Study group | Role | What they receive |
|---|---|---|
| Ceftaroline for Injection | Experimental | Not described Receives: Drug: Ceftaroline |
| IV Vancomycin and IV Aztreonam | Active comparator | Not described Receives: Drug: IV Vancomycin plus IV Aztreonam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Cure Rate at Test of Cure (TOC) (MITT Population)
Cure: Total resolution of all signs and symptoms of the baseline infection, or improvement of the infection such that no further antimicrobial therapy was necessary.
Failure: Requirement of alternative antimicrobial therapy for primary infection of cSSSI due to inadequate response, recurrence, new infection at the same site; treatment-limiting adverse event (AE); requirement for surgery due to failure of study drug; diagnosis of osteomyelitis after Study Day 8; or death caused by cSSSI.
Indeterminate: Inability to determine an outcome
Measured: 8-15 days after the end of treatment
Clinical Cure Rate of Ceftaroline Compared With That of Vancomycin Plus Aztreonam Treatment at TOC in the Clinically Evaluable (CE) Population
Measured: 8-15 days after last dose of study drug
Secondary outcomes (6)
Microbiological Success Rate at the TOC Visit
Measured: 8-15 days after last dose of study drug
Clinical Response at the End of Therapy (EOT) Visit
Measured: Last day of study drug administration
Clinical and Microbiological Response by Pathogen at the TOC Visit
Measured: 8-15 days after last dose of study drug
Clinical Relapse at the Late Follow Up (LFU) Visit
Measured: 21 to 35 days after the last dose of study drug
Microbiological Reinfection or Recurrence at the LFU Visit
Measured: 21 to 35 days after the last dose of study drug
Assess Safety
Comparisons of the number of participants with Adverse Events
Measured: First dose of study drug through TOC visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2007 (estimated)
- Study startFeb 2007
- Primary completionNov 2007
- Study completionNov 2007
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.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Bacterial InfectionsStudies 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
- 698 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ralph Corey, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00424190
- Sponsor's protocol ID
- P903-06
- Acronym
- cSSSI
- Status last verified
- Feb 2017
- First submitted
- 16 Jan 2007
- Last updated
- 14 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Dryden M, Kantecki M, Yan JL, Stone GG, Leister-Tebbe H, Wilcox M. Treatment outcomes of secondary bacteraemia in patients treated with ceftaroline fosamil: pooled results from six phase III clinical trials. J Glob Antimicrob Resist. 2022 Mar;28:108-114. doi: 10.1016/j.jgar.2021.10.027. Epub 2021 Dec 16.
PubMed 34922058Wilcox M, Yan JL, Gonzalez PL, Dryden M, Stone GG, Kantecki M. Impact of Underlying Comorbidities on Outcomes of Patients Treated with Ceftaroline Fosamil for Complicated Skin and Soft Tissue Infections: Pooled Results from Three Phase III Randomized Clinical Trials. Infect Dis Ther. 2022 Feb;11(1):217-230. doi: 10.1007/s40121-021-00557-w. Epub 2021 Nov 6.
PubMed 34741280Corey GR, Wilcox MH, Gonzalez J, Jandourek A, Wilson DJ, Friedland HD, Das S, Iaconis J, Dryden M. Ceftaroline fosamil therapy in patients with acute bacterial skin and skin-structure infections with systemic inflammatory signs: A retrospective dose comparison across three pivotal trials. Int J Antimicrob Agents. 2019 Jun;53(6):830-837. doi: 10.1016/j.ijantimicag.2019.01.016. Epub 2019 Feb 1.
PubMed 30716446Cheng K, Pypstra R, Yan JL, Hammond J. Summary of the safety and tolerability of two treatment regimens of ceftaroline fosamil: 600 mg every 8 h versus 600 mg every 12 h. J Antimicrob Chemother. 2019 Apr 1;74(4):1086-1091. doi: 10.1093/jac/dky519.
PubMed 30597021Corrado ML. Integrated safety summary of CANVAS 1 and 2 trials: Phase III, randomized, double-blind studies evaluating ceftaroline fosamil for the treatment of patients with complicated skin and skin structure infections. J Antimicrob Chemother. 2010 Nov;65 Suppl 4:iv67-iv71. doi: 10.1093/jac/dkq256.
PubMed 21115456Corey GR, Wilcox MH, Talbot GH, Thye D, Friedland D, Baculik T; CANVAS 1 investigators. CANVAS 1: the first Phase III, randomized, double-blind study evaluating ceftaroline fosamil for the treatment of patients with complicated skin and skin structure infections. J Antimicrob Chemother. 2010 Nov;65 Suppl 4:iv41-51. doi: 10.1093/jac/dkq254.
PubMed 21115454Corey GR, Wilcox M, Talbot GH, Friedland HD, Baculik T, Witherell GW, Critchley I, Das AF, Thye D. Integrated analysis of CANVAS 1 and 2: phase 3, multicenter, randomized, double-blind studies to evaluate the safety and efficacy of ceftaroline versus vancomycin plus aztreonam in complicated skin and skin-structure infection. Clin Infect Dis. 2010 Sep 15;51(6):641-50. doi: 10.1086/655827.
PubMed 20695801
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline Versus Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin and Skin Structure Infection
- ClinicalTrials.gov ID
- NCT00424190
- Acronym / sponsor ID
- cSSSI / P903-06
- Conditions
- Bacterial Infections
- Keywords
- Abscess, Antibacterial, Antibiotic, Antimicrobial, Bacterial infection, skin, Ceftaroline, Ceftaroline acetate, Cellulitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 698 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 18 Jan 2007 (estimated)
- Results
- Posted 8 Nov 2010
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 determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.
Detailed description
Additional purpose of the study is to compare ceftaroline effectivity versus Vancomycin plus Aztreonam in the treatment of complicated skin infections in adults.
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 |
|---|---|---|
| Ceftaroline for Injection | Experimental | Drug: Ceftaroline |
| IV Vancomycin and IV Aztreonam | Active comparator | Drug: IV Vancomycin plus IV Aztreonam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Skin and skin structure infection (SSSI) that involves deeper soft tissue or requires significant surgical intervention, or cellulitis or abscess on lower extremity which occurs in subjects with diabetes mellitus or well-documented peripheral vascular disease.
Key exclusion criteria (2 listed)
- Prior treatment of current cSSSI with an antimicrobial.
- Failure of vancomycin or aztreonam as therapy for the current cSSSI, or prior isolation of an organism with in vitro resistance to vancomycin or aztreonam.
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 |
|---|---|---|
| IV Vancomycin plus IV AztreonamAlso: Active Comparatorvancomycin at 1 g parenteral infused over 60 minutes followed by aztreonam 1 g infused over 60 minutes, every 12 hours, for 5 to 14 days. | Drug | IV Vancomycin and IV Aztreonam |
| CeftarolineAlso: Experimental600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days | Drug | Ceftaroline for Injection |
Primary outcome
Clinical Cure Rate at Test of Cure (TOC) (MITT Population)
Time frame: 8-15 days after the end of treatment
Cure: Total resolution of all signs and symptoms of the baseline infection, or improvement of the infection such that no further antimicrobial therapy was necessary. Failure: Requirement of alternative antimicrobial therapy for primary infection of cSSSI due to inadequate response, recurrence, new infection at the same site; treatment-limiting adverse event (AE); requirement for surgery due to failure of study drug; diagnosis of osteomyelitis after Study Day 8; or death caused by cSSSI. Indeterminate: Inability to determine an outcome
Clinical Cure Rate of Ceftaroline Compared With That of Vancomycin Plus Aztreonam Treatment at TOC in the Clinically Evaluable (CE) Population
Time frame: 8-15 days after last dose of study drug
6 secondary outcomes
Microbiological Success Rate at the TOC Visit
Time frame: 8-15 days after last dose of study drug
Clinical Response at the End of Therapy (EOT) Visit
Time frame: Last day of study drug administration
Clinical and Microbiological Response by Pathogen at the TOC Visit
Time frame: 8-15 days after last dose of study drug
Clinical Relapse at the Late Follow Up (LFU) Visit
Time frame: 21 to 35 days after the last dose of study drug
Microbiological Reinfection or Recurrence at the LFU Visit
Time frame: 21 to 35 days after the last dose of study drug
Assess Safety
Time frame: First dose of study drug through TOC visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34922058Dryden M, Kantecki M, Yan JL, Stone GG, Leister-Tebbe H, Wilcox M. Treatment outcomes of secondary bacteraemia in patients treated with ceftaroline fosamil: pooled results from six phase III clinical trials. J Glob Antimicrob Resist. 2022 Mar;28:108-114. doi: 10.1016/j.jgar.2021.10.027. Epub 2021 Dec 16.
- Derived from this study: PubMed 34741280Wilcox M, Yan JL, Gonzalez PL, Dryden M, Stone GG, Kantecki M. Impact of Underlying Comorbidities on Outcomes of Patients Treated with Ceftaroline Fosamil for Complicated Skin and Soft Tissue Infections: Pooled Results from Three Phase III Randomized Clinical Trials. Infect Dis Ther. 2022 Feb;11(1):217-230. doi: 10.1007/s40121-021-00557-w. Epub 2021 Nov 6.
- Derived from this study: PubMed 30716446Corey GR, Wilcox MH, Gonzalez J, Jandourek A, Wilson DJ, Friedland HD, Das S, Iaconis J, Dryden M. Ceftaroline fosamil therapy in patients with acute bacterial skin and skin-structure infections with systemic inflammatory signs: A retrospective dose comparison across three pivotal trials. Int J Antimicrob Agents. 2019 Jun;53(6):830-837. doi: 10.1016/j.ijantimicag.2019.01.016. Epub 2019 Feb 1.
- Derived from this study: PubMed 30597021Cheng K, Pypstra R, Yan JL, Hammond J. Summary of the safety and tolerability of two treatment regimens of ceftaroline fosamil: 600 mg every 8 h versus 600 mg every 12 h. J Antimicrob Chemother. 2019 Apr 1;74(4):1086-1091. doi: 10.1093/jac/dky519.
- Derived from this study: PubMed 21115456Corrado ML. Integrated safety summary of CANVAS 1 and 2 trials: Phase III, randomized, double-blind studies evaluating ceftaroline fosamil for the treatment of patients with complicated skin and skin structure infections. J Antimicrob Chemother. 2010 Nov;65 Suppl 4:iv67-iv71. doi: 10.1093/jac/dkq256.
- Derived from this study: PubMed 21115454Corey GR, Wilcox MH, Talbot GH, Thye D, Friedland D, Baculik T; CANVAS 1 investigators. CANVAS 1: the first Phase III, randomized, double-blind study evaluating ceftaroline fosamil for the treatment of patients with complicated skin and skin structure infections. J Antimicrob Chemother. 2010 Nov;65 Suppl 4:iv41-51. doi: 10.1093/jac/dkq254.
- Derived from this study: PubMed 20695801Corey GR, Wilcox M, Talbot GH, Friedland HD, Baculik T, Witherell GW, Critchley I, Das AF, Thye D. Integrated analysis of CANVAS 1 and 2: phase 3, multicenter, randomized, double-blind studies to evaluate the safety and efficacy of ceftaroline versus vancomycin plus aztreonam in complicated skin and skin-structure infection. Clin Infect Dis. 2010 Sep 15;51(6):641-50. doi: 10.1086/655827.
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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.
Ralph Corey, MD principal investigator
Duke University
52 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IV Vancomycin plus IV Aztreonam and Ceftaroline in people with Bacterial Infections, run by Forest Laboratories at 52 sites in 11 countries.
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 2 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 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in United States, Argentina, Russia, Germany, Poland and 6 more countries. 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 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 8 Nov 2010). 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 Cure Rate at Test of Cure (TOC) (MITT Population) (time frame: 8-15 days after the end of treatment). The study lists 2 primary outcomes in all. 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 NCT00424190, which also lists 7 linked publications.
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 14 Mar 2017.