Evaluation of Ceftaroline Fosamil Versus a Comparator in Adult Subjects With Community-acquired Bacterial Pneumonia (CABP) With Risk for Methicillin-resistant Staphylococcus Aureus

December 24, 2015 updated by: Forest Laboratories

A Multicenter, Multinational, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil Versus Ceftriaxone Plus Vancomycin in Adult Subjects With Community-acquired Bacterial Pneumonia at Risk for Infection Due to Methicillin-resistant Staphylococcus Aureus

The purpose of this study is to determine whether ceftaroline is effective and safe for the treatment of patients with Community-acquired Bacterial Pneumonia (CABP) at risk for infection due to Methicillin-resistant Staphylococcus aureus (MRSA).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A Multicenter, Multinational, Randomized, Double-blind Study to Evaluate the Efficacy and safety of Ceftaroline fosamil Versus Ceftriaxone Plus Vancomycin in Adult Subjects with Community-acquired Bacterial Pneumonia at Risk for Infection Due to Methicillin-resistant Staphylococcus aureus.

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 4

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

  • Georgia
      • Tbilisi, Georgia, 0144
        • Investigational Site
  • Hungary
      • Matrahaza, Hungary, 3233
        • Investigational Site
  • Poland
      • Lodz, Poland, 90-153
        • Investigational Site
      • Lublin, Poland, 20-954
        • Investigational Site
      • Wilkowice-Bystra, Poland, 43-365
        • Investigational Site
  • Romania
      • Bucharest, Romania, 030303
        • Investigational Site
      • Iasi, Romania, 700115
        • Investigational Site
    • Dolj
      • Craiova, Dolj, Romania, 200515
        • Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 109240
        • Investigational Site
      • St. Petersburg, Russian Federation, 196247
        • Investigational Site
      • Yaroslavl, Russian Federation, 150003
        • Investigational Site
  • Spain
      • Alicante, Spain, 03010
        • Investigational Site
      • Barcelona, Spain, 08304
        • Investigational Site
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49059
        • Investigational Site
      • Ivano-Frankivsik, Ukraine, 76018
        • Investigational Site
      • Kharkiv, Ukraine, 61115
        • Investigational Site
      • Kyiv, Ukraine, 03680
        • Investigational Site
      • Zaporizhzhya, Ukraine, 69035
        • Investigational Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85008
        • Investigational Site
    • California
      • Sylmar, California, United States, 91342
        • Investigational Site
    • Florida
      • DeLand, Florida, United States, 32720
        • Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Investigational Site
    • Kansas
      • Kansas City, Kansas, United States, 66012
        • Investigational Site
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55145
        • Investigational Site
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Investigational Site
    • New Hampshire
      • Laconia, New Hampshire, United States, 03246
        • Investigational Site
    • Ohio
      • Columbus, Ohio, United States, 43215
        • Investigational Site
      • Lima, Ohio, United States, 45801
        • Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Investigational 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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects are required to meet All of the following inclusion criteria:

    1. Male or female, ≥ 18 years old
    2. Presence of CABP requiring hospitalization
    3. Presence of CABP meeting the following criteria:

I. confirmed pneumonia (new or progressive pulmonary) II. Acute illness (≤ 7 days' duration) with at least 3 clinical signs or symptoms consistent with a lower respiratory tract infection

MRSA Risk Factors

• MRSA-positive blood culture or respiratory specimen or a risk factor for MRSA such as a history of colonization with MRSA

Exclusion Criteria:

  • Subjects must Not meet any of the following exclusion criteria at baseline:

    1. History of any hypersensitivity or allergic reaction to any β-lactam antimicrobial
    2. Suspected or microbiologically-documented infection with a pathogen known to be resistant to any of the study drugs
    3. Non-infectious causes of pulmonary infiltrates (eg, pulmonary embolism, chemical pneumonitis from aspiration, hypersensitivity pneumonia, congestive heart failure)
    4. More than 24 hours of potentially effective systemic antibacterial therapy for CABP within 96 hours before randomization
    5. End-stage renal disease [Creatinine Clearance (CrCl) < 15], including hemodialysis
    6. Evidence of significant hepatic, hematological, or immunocompromising condition

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ceftaroline
Ceftaroline fosamil 600 mg Intravenous (IV) administration over 60 minutes, every 8 hours (q8h); dosing to be adjusted for renal function; treatment duration 5 to 14 days
Drug: Ceftaroline fosamil
Ceftaroline fosamil 600 mg IV over 60 minutes q8h; treatment duration 5 to 14 days
Other Names:
  • Teflaro
  • PPI-0903
  • TAK-599
  • TAK599
  • PPI0903 Teflaro
Active Comparator: Ceftriaxone plus vancomycin
Ceftriaxone 2 g IV over 30 minutes once per day (q24h) plus vancomycin 15 mg/kg IV every 12 hours (q12h) initially and then dose adjusted based on trough concentrations; treatment duration 5 to 14 days
Drug: Ceftriaxone plus vancomycin
Ceftriaxone 2g IV over 30 minutes q24h plus vancomycin 15 mg/kg IV q12h initially and then dose adjusted based on trough concentrations; treatment duration 5 to 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Response at Study Day 4 in the Modified Intent-to-Treat (MITT) Population
Time Frame: Study Day 4

Clinical response was defined as meeting all of the following criteria:

  • Symptom Improvement - Improvement in at least 2 and no worsening of any of the following symptoms compared to baseline:

    • Cough
    • Dyspnea
    • Sputum production
    • Chest pain

  • Clinical Stability (per Infectious Diseases Society of America/American Thoracic Society (IDSA/ATS) guidelines; Mandell et al, 2007):

    • Temperature ≤ 37.8°C
    • Heart rate ≤ 100 beats/min
    • Respiratory rate ≤ 24 breaths/min
    • Systolic blood pressure ≥ 90 mmHg
    • Oxygen saturation ≥ 90%
    • Confusion/disorientation absent
Study Day 4
Clinical Outcome at Test of Cure (TOC) in the MITT Population
Time Frame: Test of Cure, an average of 3 weeks

An assessment of clinical outcome was made by the Investigator at TOC. The clinical outcome categories were:

Cure: Resolution of all acute signs and symptoms of CABP or improvement to such an extent that no further antimicrobial therapy was required

Failure: Subjects who meet either of the following criteria:

  • Incomplete resolution or worsening of CABP signs and symptoms or development of new CABP signs or symptoms requiring alternative nonstudy antimicrobial therapy
  • Death in which CABP is contributory

Indeterminate: Study data are not available for evaluation of efficacy for any reason, including:

  • Death in which CABP is clearly noncontributory
  • Lost to follow-up
  • Extenuating circumstances precluding classification as a cure or failure

A favorable clinical outcome at Test-of Cure (TOC) was clinical cure.
Test of Cure, an average of 3 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiological Outcomes by Baseline Pathogen at TOC in the Microbiological Modified Intent-to-Treat (mMITT) Population
Time Frame: Test of Cure, an average of 3 weeks
An overall microbiological outcome was derived based on the subject's baseline pathogen. As no follow-up specimens were collected at the TOC visit for any subjects, all microbiological outcomes were derived based strictly on clinical outcomes, as either presumed eradication (ie, source specimen was not available to culture and the subject was assessed as clinical cure) , presumed persistence (ie, source specimen was not available to culture and the subject was assessed as a clinical failure), or indeterminate (ie, source specimen was not available to culture and the subject's clinical response was assessed as indeterminate).
Test of Cure, an average of 3 weeks
Safety Evaluation
Time Frame: Baseline (Day 0) to Day 49
Adverse events (AEs), serious adverse events (SAEs), deaths, discontinuation due to AEs
Baseline (Day 0) to Day 49

Collaborators and Investigators

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

Sponsor

Forest Laboratories

Collaborators

AstraZeneca

Investigators

  • Study Director: Medical Monitor, Forest Laboratories Inc, an affiliate of Allergan plc

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.

Helpful Links

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

October 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

July 9, 2012

First Submitted That Met QC Criteria

July 18, 2012

First Posted (Estimate)

July 20, 2012

Study Record Updates

Last Update Posted (Estimate)

February 1, 2016

Last Update Submitted That Met QC Criteria

December 24, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P903-25

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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