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

September 1, 2017 updated by: Pfizer

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
802

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Córdoba, Argentina
        • Research Site
      • Santa Fe, Argentina
        • Research Site
  • Australia
      • Parkville, Australia
        • Research Site
  • Belgium
      • Bruxelles, Belgium
        • Research Site
  • Brazil
      • Belo Horizonte, Brazil
        • Research Site
      • Passo Fundo, Brazil
        • Research Site
      • Salvador, Brazil
        • Research Site
      • São José do Rio Preto, Brazil
        • Research Site
  • Bulgaria
      • Pleven, Bulgaria
        • Research Site
      • Ruse, Bulgaria
        • Research Site
      • Sofia, Bulgaria
        • Research Site
  • Chile
      • Temuco, Chile
        • Research Site
      • Viña del Mar, Chile
        • Research Site
  • China
      • Beijing, China
        • Research Site
      • Changchun, China
        • Research Site
      • Changsha, China
        • Research Site
      • Chengdu, China
        • Research Site
      • Chongqing, China
        • Research Site
      • Fuzhou, China
        • Research Site
      • Guangzhou, China
        • Research Site
      • Haikou, China
        • Research Site
      • Nanning, China
        • Research Site
      • Qingdao, China
        • Research Site
      • Shanghai, China
        • Research Site
      • Shenyang, China
        • Research Site
      • Shijiazhuang, China
        • Research Site
      • Wuhan, China
        • Research Site
      • Xi'an, China
        • Research Site
  • Croatia
      • Slavonski Brod, Croatia
        • Research Site
      • Zagreb, Croatia
        • Research Site
  • Czechia
      • Jihlava, Czechia
        • Research Site
      • Pardubice, Czechia
        • Research Site
  • France
      • Orleans, France
        • Research Site
  • Germany
      • Dessau, Germany
        • Research Site
      • Hanau, Germany
        • Research Site
      • Heilbronn, Germany
        • Research Site
  • Greece
      • Athens, Greece
        • Research Site
  • Hong Kong
      • Kowloon, Hong Kong
        • Research Site
      • Pokfulam, Hong Kong
        • Research Site
  • Israel
      • Haifa, Israel
        • Research Site
      • Ramat-Gan, Israel
        • Research Site
      • Safed, Israel
        • Research Site
      • Tel Aviv, Israel
        • Research Site
  • Italy
      • Milano, Italy
        • Research Site
  • Korea, Republic of
      • Ansan, Korea, Republic of
        • Research Site
      • Deagu, Korea, Republic of
        • Research Site
      • Incheon, Korea, Republic of
        • Research Site
      • Seoul, Korea, Republic of
        • Research Site
      • Won-ju, Korea, Republic of
        • Research Site
  • Mexico
      • Guadalajara, Mexico
        • Research Site
  • Peru
      • Cusco, Peru
        • Research Site
      • Lima, Peru
        • Research Site
  • Philippines
      • Manila, Philippines
        • Research Site
      • Quezon City, Philippines
        • Research Site
  • Poland
      • Lublin, Poland
        • Research Site
      • Łódź, Poland
        • Research Site
  • Romania
      • Bucharest, Romania
        • Research Site
  • Russian Federation
      • Moscow, Russian Federation
        • Research Site
      • Perm, Russian Federation
        • Research Site
      • Saint Petersburg, Russian Federation
        • Research Site
      • Smolensk, Russian Federation
        • Research Site
      • Vsevolozhsk, Russian Federation
        • Research Site
      • Yaroslavl, Russian Federation
        • Research Site
  • South Africa
      • Benoni, South Africa
        • Research Site
      • Cape Town, South Africa
        • Research Site
      • Johannesburg, South Africa
        • Research Site
      • Worcester, South Africa
        • Research Site
  • Spain
      • Barcelona, Spain
        • Research Site
      • Granada, Spain
        • Research Site
      • Madrid, Spain
        • Research Site
      • Terrassa, Spain
        • Research Site
  • Taiwan
      • Kaohsiung, Taiwan
        • Research Site
      • Taipei, Taiwan
        • Research Site
      • Yung Kang City, Taiwan
        • Research Site
  • Turkey
      • Ankara, Turkey
        • Research Site
      • Diyarbakir, Turkey
        • Research Site
      • Izmir, Turkey
        • Research Site
  • Ukraine
      • Cherkasy, Ukraine
        • Research Site
      • Ivano-Frankivsk, Ukraine
        • Research Site
      • Kharkov, Ukraine
        • Research Site
      • Odesa, Ukraine
        • Research Site
  • United States
    • California
      • Chula Vista, California, United States
        • Research Site
    • Florida
      • Orlando, Florida, United States
        • Research Site
      • West Palm Beach, Florida, United States
        • Research Site
    • Indiana
      • Carmel, Indiana, United States
        • Research Site
    • Kentucky
      • Hazard, Kentucky, United States
        • Research Site
    • Massachusetts
      • Springfield, Massachusetts, United States
        • Research Site
    • Michigan
      • Detroit, Michigan, United States
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States
        • Research Site
    • New York
      • Garden City, New York, United States
        • Research Site
    • Texas
      • Bellaire, Texas, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
7 to 20 days after the last dose of study drug
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 to 20 days after the last dose of study drug

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
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
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.
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)
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.
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)
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.
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
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.
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
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.
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
Per-pathogen microbiological response at TOC by baseline pathogen from site of skin infection in ME analysis set
7 to 20 days after the last dose of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Forest Laboratories

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: David Melnick, MSD, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 26, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 6, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D3720C00001
  • 2011-004013-16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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