Complicated Skin and Soft Tissue InfectionPhase 3NCT01499277
Evaluation of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections
A Phase 3 study testing Ceftaroline fosamil, Vancomycin and Aztreonam in people with Complicated Skin and Soft Tissue Infection, run by Pfizer at 91 sites in 28 countries.
Trial summary
The purpose of this study is to evaluate the effects of Ceftaroline Fosamil versus Vancomycin plus Aztreonam in treatment of patients with complicated bacterial skin and soft tissue infections. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Complicated Skin and Soft Tissue Infection
- What is being tested?
- Ceftaroline fosamil, Vancomycin and Aztreonam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 802 participants
- Where
- 91 sitesin 28 countries
- Study dates
- May 2012to Jan 2015
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 18 years or older
- Complicated skin and skin structure infection (cSSTI)
- Infection of sufficient severity to warrant hospitalization
- Infection of sufficient severity such that it is expected to require at least 5 days of intravenous antibiotic therapy
Who cannot join
- Received systemic antibacterial drugs for greater than 24 hours within 96 hours prior to first dose of study drug
- Uncomplicated skin and skin structure infections, skin infections suspected to be caused by viral or fungal pathogens
- Diabetic foot infections, decubitus ulcers, ulcers due to peripheral vascular disease
- Infection caused by human or animal bites, sternal wound infections, bone infection or arthritis due to an infection, critical limb ischemia of the affected limb
- Chronic liver disease or severe impaired renal function, severe low white blood cell count, burns on greater than 15% of total body surface area, necrotizing skin infection, amputation required of primary site of infection, sustained shock
Trial locations and contacts
91 sites in 28 countries.
91 sites in 28 countries
China15 sites
Research Site
Beijing
Research Site
Changchun
Research Site
Changsha
Research Site
Chengdu
Research Site
Chongqing
Research Site
Fuzhou
Research Site
Guangzhou
Research Site
Haikou
Research Site
Nanning
Research Site
Qingdao
Research Site
Shanghai
Research Site
Shenyang
Research Site
Shijiazhuang
Research Site
Wuhan
Research Site
Xi'an
United States10 sites
Research Site
Bellaire, Texas
Research Site
Carmel, Indiana
Research Site
Chula Vista, California
Research Site
Detroit, Michigan
Research Site
Garden City, New York
Research Site
Hazard, Kentucky
Research Site
Las Vegas, Nevada
Research Site
Orlando, Florida
Research Site
Springfield, Massachusetts
Research Site
West Palm Beach, Florida
Russia6 sites
Research Site
Moscow
Research Site
Perm
Research Site
Saint Petersburg
Research Site
Smolensk
Research Site
Vsevolozhsk
Research Site
Yaroslavl
South Korea5 sites
Research Site
Ansan
Research Site
Deagu
Research Site
Incheon
Research Site
Seoul
Research Site
Wŏnju
Brazil4 sites
Research Site
Belo Horizonte
Research Site
Passo Fundo
Research Site
Salvador
Research Site
São José do Rio Preto
Israel4 sites
Research Site
Haifa
Research Site
Ramat Gan
Research Site
Safed
Research Site
Tel Aviv
South Africa4 sites
Research Site
Benoni
Research Site
Cape Town
Research Site
Johannesburg
Research Site
Worcester
Spain4 sites
Research Site
Barcelona
Research Site
Granada
Research Site
Madrid
Research Site
Terrassa
Ukraine4 sites
Research Site
Cherkasy
Research Site
Ivano-Frankivsk
Research Site
Kharkiv
Research Site
Odesa
Taiwan3 sites
Research Site
Kaohsiung City
Research Site
Taipei
Research Site
Yung Kang City
Turkey (Türkiye)3 sites
Research Site
Ankara
Research Site
Diyarbakır
Research Site
Izmir
About this study
Official title: A Phase III, Multicentre, Randomised, Double-Blind Comparative Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil (600 mg Every 8 Hours) Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Complicated Bacterial Skin and Soft Tissue Infections With Evidence of Systemic Inflammatory Response or Underlying Comorbidities
The purpose of this study is to evaluate the effects of Ceftaroline Fosamil versus Vancomycin plus Aztreonam in treatment of patients with complicated bacterial skin and soft tissue infections.
Read the detailed description
A Phase III, Multicentre, Randomised, Double-Blind Comparative Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil (600 mg every 8 hours) Versus Vancomycin Plus Aztreonam in the Treatment of Patients with Complicated Bacterial Skin and Soft Tissue Infections With Evidence of Systemic Inflammatory Response or Underlying Comorbidities
- Being tested
- Ceftaroline fosamil, Vancomycin, Aztreonam
- Keywords
- complicated skin and soft tissue infections (cSSTI), skin infection, ceftaroline, wound infection, cellulitis, burn infection, bacterial infection, vancomycin
- Medical subject headings
- Soft Tissue Infections, Cellulitis, Wound Infection, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceftaroline fosamilDrug
IV ceftaroline 600mg every 8 hours
VancomycinDrug
IV vancomycin 15mg/kg every 12 hours
AztreonamDrug
IV aztreonam 1 g every 8 hours
| Study group | Role | What they receive |
|---|---|---|
| Ceftaroline fosamil | Experimental | Patients will receive 600 mg of ceftaroline fosamil administered as a 120-minute intravenous infusion very 8 hours. Each dose will be infused in a volume of 250 mL over 120-minutes followed by aztreonam placebo in a volume of 100 mL infused over 30 minutes every 8 hours. In addition vancomycin placebo will be given in a volume of 250 mL infused over 120 minutes every 12 hours. Doses will be adjusted according to the patient's renal function. Receives: Drug: Ceftaroline fosamil |
| Vancomycin plus aztreonam | Active comparator | Patients will receive combination of vancomycin plus aztreonam. Dose of vancomycin will be based on the patient's actual weight and will receive intravenous vancomycin every 12 hours with each dose infused over 120-minutes. Aztreonam dose will be 1 gram intravenously in a volume of 100 mL infused over 30 minutes every 8 hours. In addition, ceftaroline fosamil placebo will be given in a volume of 250 mL infused over 120 minutes every 8 hours. Doses adjusted according to patients renal function Receives: Drug: Vancomycin; Drug: Aztreonam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response at Test of Cure (TOC) in Modified Intent-to-treat (MITT) Analysis Set
The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Clinical cure rate is measured by comparing the participant's signs and symptoms at TOC visit to those recorded at study baseline.
Measured: 7 to 20 days after the last dose of study drug
Clinical Response at TOC in Clinically Evaluable (CE) Analysis Set
The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical cure rate is measured by comparing the participant's signs and symptoms at TOC visit to those recorded at study baseline.
Measured: 7 to 20 days after the last dose of study drug
Secondary outcomes (7)
Per Patient Microbiological Response at TOC in Microbiologically Modified-intent-to-treat (mMITT) Analysis Set
Difference in microbiological favorable response rate at TOC in mMITT analysis set. Favorable microbiological response rate is measured by comparing TOC microbiological data to baseline microbiological data. In the absence of TOC microbiological data it is presumed from the clinical response.
Measured: 7 to 20 days after the last dose of study drug
Per-patient Micro Response at TOC in Microbiologically Evaluable (ME) Analysis Set
Difference in microbiological favorable response rate at TOC in ME. Favourable microbiological response rate is measured by comparing TOC microbiological data to baseline microbiological data. In the absence of TOC microbiological data it is presumed from the clinical response.
Measured: 7 to 20 days after the last dose of study drug
Clinical Response at End of Treatment (EOT) in MITT Analysis Set
The observed difference in the clinical cure rates at EOT (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Clinical cure rate is measured by comparing the participant's signs and symptoms at EOT visit to those recorded at study baseline.
Measured: On day of last dose of study drug (or + 1 day)
Clinical Response at EOT in CE Analysis Set
The observed difference in the clinical cure rates at EOT (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical cure rate is measured by comparing the participant's signs and symptoms at EOT visit to those recorded at study baseline.
Measured: On day of last dose of study drug (or +1 day)
Clinical Relapse at Late Follow-up (LFU) in CE Patients Who Were Cured at TOC
The observed difference in the clinical relapse rates at LFU (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical relapse rate at LFU is measured by comparing a patient's signs and symptoms at late follow-up to those when they were cured at TOC.
Measured: 21 to 42 days after the last dose of study drug
Early Response at 48 to 72 Hours of Treatment in MITT Analysis Set
The observed difference in the early success rates at 48 to 72 hours of treatment (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Early response rate as measured by comparing the participant's signs and symptoms at the 48-72 hour visit to those recorded at study baseline.
Measured: 48 to 72 hours after first dose of study drug
Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME
Per-pathogen microbiological response at TOC by baseline pathogen from site of skin infection in ME analysis set
Measured: 7 to 20 days after the last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2011 (estimated)
- Study startMay 2012
- Primary completionJun 2014
- Study completionJan 2015
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 Complicated Skin and Soft Tissue InfectionStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 802 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Forest Laboratories
- Responsible party
- Sponsor
- Investigators
- David Melnick, MSD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01499277
- Sponsor's protocol ID
- D3720C00001
- Other IDs
- 2011-004013-16
- Status last verified
- Sep 2017
- First submitted
- 16 Dec 2011
- Last updated
- 6 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
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 34741280Sanchez-Garcia M, Hammond J, Yan JL, Kantecki M, Ansari W, Dryden M. Baseline Characteristics and Outcomes Among Patients with Complicated Skin and Soft Tissue Infections Admitted to the Intensive Care Unit: Analysis of the Phase 3 COVERS Randomized Trial of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam. Infect Dis Ther. 2020 Sep;9(3):609-623. doi: 10.1007/s40121-020-00297-3. Epub 2020 Jun 30.
PubMed 32607967Corey 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 30597021Das S, Li J, Iaconis J, Zhou D, Stone GG, Yan JL, Melnick D. Ceftaroline fosamil doses and breakpoints for Staphylococcus aureus in complicated skin and soft tissue infections. J Antimicrob Chemother. 2019 Feb 1;74(2):425-431. doi: 10.1093/jac/dky439.
PubMed 30380060Dryden M, Zhang Y, Wilson D, Iaconis JP, Gonzalez J. A Phase III, randomized, controlled, non-inferiority trial of ceftaroline fosamil 600 mg every 8 h versus vancomycin plus aztreonam in patients with complicated skin and soft tissue infection with systemic inflammatory response or underlying comorbidities. J Antimicrob Chemother. 2016 Dec;71(12):3575-3584. doi: 10.1093/jac/dkw333. Epub 2016 Sep 1.
PubMed 27585969
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicentre, Randomised, Double-Blind Comparative Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil (600 mg Every 8 Hours) Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Complicated Bacterial Skin and Soft Tissue Infections With Evidence of Systemic Inflammatory Response or Underlying Comorbidities
- ClinicalTrials.gov ID
- NCT01499277
- Acronym / sponsor ID
- D3720C00001
- Keywords
- complicated skin and soft tissue infections (cSSTI), skin infection, ceftaroline, wound infection, cellulitis, burn infection, bacterial infection, vancomycin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 802 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Forest Laboratories
- Study start
- May 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 26 Dec 2011 (estimated)
- Results
- Posted 9 Nov 2015
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 evaluate the effects of Ceftaroline Fosamil versus Vancomycin plus Aztreonam in treatment of patients with complicated bacterial skin and soft tissue infections.
Detailed description
A Phase III, Multicentre, Randomised, Double-Blind Comparative Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil (600 mg every 8 hours) Versus Vancomycin Plus Aztreonam in the Treatment of Patients with Complicated Bacterial Skin and Soft Tissue Infections With Evidence of Systemic Inflammatory Response or Underlying Comorbidities
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 fosamil | Experimental | Drug: Ceftaroline fosamilPatients will receive 600 mg of ceftaroline fosamil administered as a 120-minute intravenous infusion very 8 hours. Each dose will be infused in a volume of 250 mL over 120-minutes followed by aztreonam placebo in a volume of 100 mL infused over 30 minutes every 8 hours. In addition vancomycin placebo will be given in a volume of 250 mL infused over 120 minutes every 12 hours. Doses will be adjusted according to the patient's renal function. |
| Vancomycin plus aztreonam | Active comparator | Drug: Vancomycin, Drug: AztreonamPatients will receive combination of vancomycin plus aztreonam. Dose of vancomycin will be based on the patient's actual weight and will receive intravenous vancomycin every 12 hours with each dose infused over 120-minutes. Aztreonam dose will be 1 gram intravenously in a volume of 100 mL infused over 30 minutes every 8 hours. In addition, ceftaroline fosamil placebo will be given in a volume of 250 mL infused over 120 minutes every 8 hours. Doses adjusted according to patients renal function |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, aged 18 years or older
- Complicated skin and skin structure infection (cSSTI)
- Infection of sufficient severity to warrant hospitalization
- Infection of sufficient severity such that it is expected to require at least 5 days of intravenous antibiotic therapy
Key exclusion criteria (5 listed)
- Received systemic antibacterial drugs for greater than 24 hours within 96 hours prior to first dose of study drug
- Uncomplicated skin and skin structure infections, skin infections suspected to be caused by viral or fungal pathogens
- Diabetic foot infections, decubitus ulcers, ulcers due to peripheral vascular disease
- Infection caused by human or animal bites, sternal wound infections, bone infection or arthritis due to an infection, critical limb ischemia of the affected limb
- Chronic liver disease or severe impaired renal function, severe low white blood cell count, burns on greater than 15% of total body surface area, necrotizing skin infection, amputation required of primary site of infection, sustained shock
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 |
|---|---|---|
| Ceftaroline fosamilIV ceftaroline 600mg every 8 hours | Drug | Ceftaroline fosamil |
| VancomycinIV vancomycin 15mg/kg every 12 hours | Drug | Vancomycin plus aztreonam |
| AztreonamIV aztreonam 1 g every 8 hours | Drug | Vancomycin plus aztreonam |
Primary outcome
Clinical Response at Test of Cure (TOC) in Modified Intent-to-treat (MITT) Analysis Set
Time frame: 7 to 20 days after the last dose of study drug
The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Clinical cure rate is measured by comparing the participant's signs and symptoms at TOC visit to those recorded at study baseline.
Clinical Response at TOC in Clinically Evaluable (CE) Analysis Set
Time frame: 7 to 20 days after the last dose of study drug
The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical cure rate is measured by comparing the participant's signs and symptoms at TOC visit to those recorded at study baseline.
7 secondary outcomes
Per Patient Microbiological Response at TOC in Microbiologically Modified-intent-to-treat (mMITT) Analysis Set
Time frame: 7 to 20 days after the last dose of study drug
Per-patient Micro Response at TOC in Microbiologically Evaluable (ME) Analysis Set
Time frame: 7 to 20 days after the last dose of study drug
Clinical Response at End of Treatment (EOT) in MITT Analysis Set
Time frame: On day of last dose of study drug (or + 1 day)
Clinical Response at EOT in CE Analysis Set
Time frame: On day of last dose of study drug (or +1 day)
Clinical Relapse at Late Follow-up (LFU) in CE Patients Who Were Cured at TOC
Time frame: 21 to 42 days after the last dose of study drug
Early Response at 48 to 72 Hours of Treatment in MITT Analysis Set
Time frame: 48 to 72 hours after first dose of study drug
Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME
Time frame: 7 to 20 days after the last dose of study drug
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 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 32607967Sanchez-Garcia M, Hammond J, Yan JL, Kantecki M, Ansari W, Dryden M. Baseline Characteristics and Outcomes Among Patients with Complicated Skin and Soft Tissue Infections Admitted to the Intensive Care Unit: Analysis of the Phase 3 COVERS Randomized Trial of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam. Infect Dis Ther. 2020 Sep;9(3):609-623. doi: 10.1007/s40121-020-00297-3. Epub 2020 Jun 30.
- 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 30380060Das S, Li J, Iaconis J, Zhou D, Stone GG, Yan JL, Melnick D. Ceftaroline fosamil doses and breakpoints for Staphylococcus aureus in complicated skin and soft tissue infections. J Antimicrob Chemother. 2019 Feb 1;74(2):425-431. doi: 10.1093/jac/dky439.
- Derived from this study: PubMed 27585969Dryden M, Zhang Y, Wilson D, Iaconis JP, Gonzalez J. A Phase III, randomized, controlled, non-inferiority trial of ceftaroline fosamil 600 mg every 8 h versus vancomycin plus aztreonam in patients with complicated skin and soft tissue infection with systemic inflammatory response or underlying comorbidities. J Antimicrob Chemother. 2016 Dec;71(12):3575-3584. doi: 10.1093/jac/dkw333. Epub 2016 Sep 1.
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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.
David Melnick, MSD study director
AstraZeneca
91 sites in 28 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ceftaroline fosamil, Vancomycin and Aztreonam in people with Complicated Skin and Soft Tissue Infection, run by Pfizer at 91 sites in 28 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 4 inclusion and 5 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 6 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 91 sites in China, United States, Russia, South Korea, Brazil and 23 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 9 Nov 2015). 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 Response at Test of Cure (TOC) in Modified Intent-to-treat (MITT) Analysis Set (time frame: 7 to 20 days after the last dose of study drug). 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 NCT01499277, 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 6 Sep 2017.