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

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ClinicalTrials.gov Identifier: NCT02202135
Recruitment Status : Terminated (Overall study status is changed to "Terminated" due to low enrollment)
First Posted : July 28, 2014
Results First Posted : March 31, 2016
Last Update Posted : September 6, 2017
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Complicated Skin and Soft Tissue Infection Drug: Ceftaroline fosamil Drug: Vancomycin Drug: Aztreonam Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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) vs 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 Start Date : June 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Ceftaroline fosamil
IV ceftaroline 600mg every 8 hours

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
Drug: Vancomycin
IV vancomycin 15mg/kg every 12 hours

Drug: Aztreonam
IV aztreonam 1 g every 8 hours




Primary Outcome Measures :
  1. Clinical Response at TOC [ Time Frame: 7 to 20 days after last dose of study drug ]
    Clinical cure is defined as resolution or improvement of signs and symptoms compared to baseline and no further antimicrobial therapy is necessary. Clinical failure is defined as any of the following: persistence or worsening in signs or symptoms, or requirement for concomitant antibiotic therapy, or requirement of an unplanned surgical intervention >48 hours after the first dose, or death caused by skin infection, or an AE leading to study drug discontinuation with alternative antimicrobial therapy required, or diagnosis of osteomyelitis >=8 days after the first dose.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. patients must have a positive culture for MRSA that has been obtained from the skin infection site and/or blood samples at any time within the 72hrs before the first dose.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202135


Locations
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Argentina
Research site
Cordoba, Argentina
Brazil
Research site
Salvador, Bahia, Brazil
Research site
Passo Fundo, Rio Grande do Sul, Brazil
Research site
Sao Jose do Rio Preto, Brazil
Bulgaria
Research site
Pleven, Bulgaria
Chile
Research site
Temuco, Chile
Croatia
Research site
Zagreb, Croatia
Greece
Research site
Athens, Greece
Israel
Research site
Haifa, Israel
Research site
Ramat-Gan, Israel
Research site
Safed, Israel
Research site
Tel-Aviv, Israel
Italy
Research site
Milano, Italy
Poland
Research site
Lodz, Poland
Romania
Research site
Bucharest, Romania
South Africa
Research site
Dundee, South Africa
Research site
Worcester, South Africa
Spain
Research site
Granada, Spain
Research site
Terrassa, Spain
Turkey
Research site
Ankara, Turkey
Research site
Diyarbakir, Turkey
Research site
Izmir, Turkey
Sponsors and Collaborators
Pfizer
Forest Laboratories
Investigators
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Study Director: David Melnick, MSD AstraZeneca

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02202135     History of Changes
Other Study ID Numbers: D3720C00001sub
First Posted: July 28, 2014    Key Record Dates
Results First Posted: March 31, 2016
Last Update Posted: September 6, 2017
Last Verified: September 2017
Keywords provided by Pfizer:
complicated skin and soft tissue infections (cSSTI)
skin infection
ceftaroline
wound infection
cellulitis
burn infection
bacterial infection
vancomycin
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Soft Tissue Infections
Vancomycin
Ceftaroline fosamil
Cephalosporins
Aztreonam
Anti-Bacterial Agents
Anti-Infective Agents