Evaluation of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections

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NCT01499277

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Study Location
Research Site
Chula Vista, California, , United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Complicated Skin and Soft Tissue Infection
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-99 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Complicated Skin and Soft Tissue InfectionEvaluation of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections
NCT01499277
  1. Chula Vista, California
  2. Orlando, Florida
  3. West Palm Beach, Florida
  4. Carmel, Indiana
  5. Hazard, Kentucky
  6. Springfield, Massachusetts
  7. Detroit, Michigan
  8. Las Vegas, Nevada
  9. Garden City, New York
  10. Bellaire, Texas
  11. Córdoba,
  12. Santa Fe,
  13. Parkville,
  14. Bruxelles,
  15. Belo Horizonte,
  16. Passo Fundo,
  17. Salvador,
  18. São José do Rio Preto,
  19. Pleven,
  20. Ruse,
  21. Sofia,
  22. Temuco,
  23. Viña del Mar,
  24. Beijing,
  25. Changchun,
  26. Changsha,
  27. Chengdu,
  28. Chongqing,
  29. Fuzhou,
  30. Guangzhou,
  31. Haikou,
  32. Nanning,
  33. Qingdao,
  34. Shanghai,
  35. Shenyang,
  36. Shijiazhuang,
  37. Wuhan,
  38. Xi'an,
  39. Slavonski Brod,
  40. Zagreb,
  41. Jihlava,
  42. Pardubice,
  43. Orleans,
  44. Dessau,
  45. Hanau,
  46. Heilbronn,
  47. Athens,
  48. Kowloon,
  49. Pokfulam,
  50. Haifa,
  51. Ramat-Gan,
  52. Safed,
  53. Tel Aviv,
  54. Milano,
  55. Ansan,
  56. Deagu,
  57. Incheon,
  58. Seoul,
  59. Won-ju,
  60. Guadalajara,
  61. Cusco,
  62. Lima,
  63. Manila,
  64. Quezon City,
  65. Lublin,
  66. Łódź,
  67. Bucharest,
  68. Moscow,
  69. Perm,
  70. Saint Petersburg,
  71. Smolensk,
  72. Vsevolozhsk,
  73. Yaroslavl,
  74. Benoni,
  75. Cape Town,
  76. Johannesburg,
  77. Worcester,
  78. Barcelona,
  79. Granada,
  80. Madrid,
  81. Terrassa,
  82. Kaohsiung,
  83. Taipei,
  84. Yung Kang City,
  85. Ankara,
  86. Diyarbakir,
  87. Izmir,
  88. Cherkasy,
  89. Ivano-Frankivsk,
  90. Kharkov,
  91. Odesa,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Complicated Skin and Soft Tissue InfectionEvaluation of Ceftaroline Fosamil vs Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections.
NCT02202135
  1. Cordoba,
  2. Salvador, Bahia
  3. Passo Fundo, Rio Grande do Sul
  4. Sao Jose do Rio Preto,
  5. Pleven,
  6. Temuco,
  7. Zagreb,
  8. Athens,
  9. Haifa,
  10. Ramat-Gan,
  11. Safed,
  12. Tel-Aviv,
  13. Milano,
  14. Lodz,
  15. Bucharest,
  16. Dundee,
  17. Worcester,
  18. Granada,
  19. Terrassa,
  20. Ankara,
  21. Diyarbakir,
  22. Izmir,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Evaluation of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections
Official Title  ICMJE 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
Brief 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Complicated Skin and Soft Tissue Infection
Intervention  ICMJE
  • Drug: Ceftaroline fosamil
    IV ceftaroline 600mg every 8 hours
  • Drug: Vancomycin
    IV vancomycin 15mg/kg every 12 hours
  • Drug: Aztreonam
    IV aztreonam 1 g every 8 hours
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Ceftaroline fosamil
  • 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
    Interventions:
    • Drug: Vancomycin
    • Drug: Aztreonam
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 7, 2015)		802
Original Estimated Enrollment  ICMJE
 (submitted: December 22, 2011)		765
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Brazil,   Bulgaria,   Chile,   China,   Croatia,   Czechia,   France,   Germany,   Greece,   Hong Kong,   Israel,   Italy,   Korea, Republic of,   Mexico,   Peru,   Philippines,   Poland,   Romania,   Russian Federation,   South Africa,   Spain,   Taiwan,   Turkey,   Ukraine,   United States
Removed Location Countries Austria,   Colombia,   Czech Republic,   Hungary,   India,   Slovakia,   Thailand,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT01499277
Other Study ID Numbers  ICMJE D3720C00001
2011-004013-16
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Forest Laboratories
Investigators  ICMJE
Study Director:David Melnick, MSDAstraZeneca
PRS Account Pfizer
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP