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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01499277




Registration number
NCT01499277
Ethics application status
Date submitted
16/12/2011
Date registered
26/12/2011
Date last updated
6/09/2017

Titles & IDs
Public title
Evaluation of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections
Scientific 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
Secondary ID [1] 0 0
2011-004013-16
Secondary ID [2] 0 0
D3720C00001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Complicated Skin and Soft Tissue Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ceftaroline fosamil
Treatment: Drugs - Vancomycin
Treatment: Drugs - Aztreonam

Experimental: Ceftaroline fosamil - 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.

Active comparator: Vancomycin plus aztreonam - 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


Treatment: Drugs: Ceftaroline fosamil
IV ceftaroline 600mg every 8 hours

Treatment: Drugs: Vancomycin
IV vancomycin 15mg/kg every 12 hours

Treatment: Drugs: Aztreonam
IV aztreonam 1 g every 8 hours
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical Response at Test of Cure (TOC) in Modified Intent-to-treat (MITT) Analysis Set
Timepoint [1] 0 0
7 to 20 days after the last dose of study drug
Primary outcome [2] 0 0
Clinical Response at TOC in Clinically Evaluable (CE) Analysis Set
Timepoint [2] 0 0
7 to 20 days after the last dose of study drug
Secondary outcome [1] 0 0
Per Patient Microbiological Response at TOC in Microbiologically Modified-intent-to-treat (mMITT) Analysis Set
Timepoint [1] 0 0
7 to 20 days after the last dose of study drug
Secondary outcome [2] 0 0
Per-patient Micro Response at TOC in Microbiologically Evaluable (ME) Analysis Set
Timepoint [2] 0 0
7 to 20 days after the last dose of study drug
Secondary outcome [3] 0 0
Clinical Response at End of Treatment (EOT) in MITT Analysis Set
Timepoint [3] 0 0
On day of last dose of study drug (or + 1 day)
Secondary outcome [4] 0 0
Clinical Response at EOT in CE Analysis Set
Timepoint [4] 0 0
On day of last dose of study drug (or +1 day)
Secondary outcome [5] 0 0
Clinical Relapse at Late Follow-up (LFU) in CE Patients Who Were Cured at TOC
Timepoint [5] 0 0
21 to 42 days after the last dose of study drug
Secondary outcome [6] 0 0
Early Response at 48 to 72 Hours of Treatment in MITT Analysis Set
Timepoint [6] 0 0
48 to 72 hours after first dose of study drug
Secondary outcome [7] 0 0
Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME
Timepoint [7] 0 0
7 to 20 days after the last dose of study drug

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2015
Sample size
Target
Accrual to date
Final
802
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Parkville
Recruitment postcode(s) [1] 0 0
- Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Nevada
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
Argentina
State/province [10] 0 0
Córdoba
Country [11] 0 0
Argentina
State/province [11] 0 0
Santa Fe
Country [12] 0 0
Belgium
State/province [12] 0 0
Bruxelles
Country [13] 0 0
Brazil
State/province [13] 0 0
Belo Horizonte
Country [14] 0 0
Brazil
State/province [14] 0 0
Passo Fundo
Country [15] 0 0
Brazil
State/province [15] 0 0
Salvador
Country [16] 0 0
Brazil
State/province [16] 0 0
São José do Rio Preto
Country [17] 0 0
Bulgaria
State/province [17] 0 0
Pleven
Country [18] 0 0
Bulgaria
State/province [18] 0 0
Ruse
Country [19] 0 0
Bulgaria
State/province [19] 0 0
Sofia
Country [20] 0 0
Chile
State/province [20] 0 0
Temuco
Country [21] 0 0
Chile
State/province [21] 0 0
Viña del Mar
Country [22] 0 0
China
State/province [22] 0 0
Beijing
Country [23] 0 0
China
State/province [23] 0 0
Changchun
Country [24] 0 0
China
State/province [24] 0 0
Changsha
Country [25] 0 0
China
State/province [25] 0 0
Chengdu
Country [26] 0 0
China
State/province [26] 0 0
Chongqing
Country [27] 0 0
China
State/province [27] 0 0
Fuzhou
Country [28] 0 0
China
State/province [28] 0 0
Guangzhou
Country [29] 0 0
China
State/province [29] 0 0
Haikou
Country [30] 0 0
China
State/province [30] 0 0
Nanning
Country [31] 0 0
China
State/province [31] 0 0
Qingdao
Country [32] 0 0
China
State/province [32] 0 0
Shanghai
Country [33] 0 0
China
State/province [33] 0 0
Shenyang
Country [34] 0 0
China
State/province [34] 0 0
Shijiazhuang
Country [35] 0 0
China
State/province [35] 0 0
Wuhan
Country [36] 0 0
China
State/province [36] 0 0
Xi'an
Country [37] 0 0
Croatia
State/province [37] 0 0
Slavonski Brod
Country [38] 0 0
Croatia
State/province [38] 0 0
Zagreb
Country [39] 0 0
Czechia
State/province [39] 0 0
Jihlava
Country [40] 0 0
Czechia
State/province [40] 0 0
Pardubice
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France
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Orleans
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Germany
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Dessau
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Germany
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Hanau
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Germany
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Heilbronn
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Greece
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Athens
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Hong Kong
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Kowloon
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Hong Kong
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Pokfulam
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Israel
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Haifa
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Israel
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Ramat-Gan
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Israel
State/province [50] 0 0
Safed
Country [51] 0 0
Israel
State/province [51] 0 0
Tel Aviv
Country [52] 0 0
Italy
State/province [52] 0 0
Milano
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Korea, Republic of
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Ansan
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Korea, Republic of
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Deagu
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Korea, Republic of
State/province [55] 0 0
Incheon
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Korea, Republic of
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Seoul
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Korea, Republic of
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Won-ju
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Mexico
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Guadalajara
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Peru
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Cusco
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Peru
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Lima
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Philippines
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Manila
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Philippines
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Quezon City
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Poland
State/province [63] 0 0
Lublin
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Poland
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Lódz
Country [65] 0 0
Romania
State/province [65] 0 0
Bucharest
Country [66] 0 0
Russian Federation
State/province [66] 0 0
Moscow
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Russian Federation
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Perm
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Russian Federation
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Saint Petersburg
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Russian Federation
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Smolensk
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Russian Federation
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Vsevolozhsk
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Russian Federation
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Yaroslavl
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South Africa
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Benoni
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South Africa
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Cape Town
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South Africa
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Johannesburg
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South Africa
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Worcester
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Spain
State/province [76] 0 0
Barcelona
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Spain
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Granada
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Spain
State/province [78] 0 0
Madrid
Country [79] 0 0
Spain
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Terrassa
Country [80] 0 0
Taiwan
State/province [80] 0 0
Kaohsiung
Country [81] 0 0
Taiwan
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Taipei
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Taiwan
State/province [82] 0 0
Yung Kang City
Country [83] 0 0
Turkey
State/province [83] 0 0
Ankara
Country [84] 0 0
Turkey
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Diyarbakir
Country [85] 0 0
Turkey
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Izmir
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Ukraine
State/province [86] 0 0
Cherkasy
Country [87] 0 0
Ukraine
State/province [87] 0 0
Ivano-Frankivsk
Country [88] 0 0
Ukraine
State/province [88] 0 0
Kharkov
Country [89] 0 0
Ukraine
State/province [89] 0 0
Odesa

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Forest Laboratories
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Melnick, MSD
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01499277