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

Primary Purpose

Infections

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Ceftaroline fosamil
Ceftriaxone plus vancomycin
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infections focused on measuring Infections, Teflaro, cephalosporin, Ceftaroline, antibiotics, pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Investigational Site
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  • Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ceftaroline

Ceftriaxone plus vancomycin

Arm Description

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

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

Outcomes

Primary Outcome Measures

Clinical Response at Study Day 4 in the Modified Intent-to-Treat (MITT) Population
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
Clinical Outcome at Test of Cure (TOC) in the MITT Population
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.

Secondary Outcome Measures

Full Information

First Posted
July 9, 2012
Last Updated
December 24, 2015
Sponsor
Forest Laboratories
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01645735
Brief Title
Evaluation of Ceftaroline Fosamil Versus a Comparator in Adult Subjects With Community-acquired Bacterial Pneumonia (CABP) With Risk for Methicillin-resistant Staphylococcus Aureus
Official Title
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

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections
Keywords
Infections, Teflaro, cephalosporin, Ceftaroline, antibiotics, pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ceftaroline
Arm Type
Experimental
Arm Description
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
Arm Title
Ceftriaxone plus vancomycin
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Ceftaroline fosamil
Other Intervention Name(s)
Teflaro, PPI-0903, TAK-599, TAK599, PPI0903 Teflaro
Intervention Description
Ceftaroline fosamil 600 mg IV over 60 minutes q8h; treatment duration 5 to 14 days
Intervention Type
Drug
Intervention Name(s)
Ceftriaxone plus vancomycin
Intervention Description
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
Primary Outcome Measure Information:
Title
Clinical Response at Study Day 4 in the Modified Intent-to-Treat (MITT) Population
Description
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
Time Frame
Study Day 4
Title
Clinical Outcome at Test of Cure (TOC) in the MITT Population
Description
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.
Time Frame
Test of Cure, an average of 3 weeks
Other Pre-specified Outcome Measures:
Title
Microbiological Outcomes by Baseline Pathogen at TOC in the Microbiological Modified Intent-to-Treat (mMITT) Population
Description
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).
Time Frame
Test of Cure, an average of 3 weeks
Title
Safety Evaluation
Description
Adverse events (AEs), serious adverse events (SAEs), deaths, discontinuation due to AEs
Time Frame
Baseline (Day 0) to Day 49

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects are required to meet All of the following inclusion criteria: Male or female, ≥ 18 years old Presence of CABP requiring hospitalization 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: History of any hypersensitivity or allergic reaction to any β-lactam antimicrobial Suspected or microbiologically-documented infection with a pathogen known to be resistant to any of the study drugs Non-infectious causes of pulmonary infiltrates (eg, pulmonary embolism, chemical pneumonitis from aspiration, hypersensitivity pneumonia, congestive heart failure) More than 24 hours of potentially effective systemic antibacterial therapy for CABP within 96 hours before randomization End-stage renal disease [Creatinine Clearance (CrCl) < 15], including hemodialysis Evidence of significant hepatic, hematological, or immunocompromising condition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Forest Laboratories Inc, an affiliate of Allergan plc
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85008
Country
United States
Facility Name
Investigational Site
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
Facility Name
Investigational Site
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Investigational Site
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66012
Country
United States
Facility Name
Investigational Site
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55145
Country
United States
Facility Name
Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Investigational Site
City
Laconia
State/Province
New Hampshire
ZIP/Postal Code
03246
Country
United States
Facility Name
Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Investigational Site
City
Lima
State/Province
Ohio
ZIP/Postal Code
45801
Country
United States
Facility Name
Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Investigational Site
City
Tbilisi
ZIP/Postal Code
0144
Country
Georgia
Facility Name
Investigational Site
City
Matrahaza
ZIP/Postal Code
3233
Country
Hungary
Facility Name
Investigational Site
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Investigational Site
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Investigational Site
City
Wilkowice-Bystra
ZIP/Postal Code
43-365
Country
Poland
Facility Name
Investigational Site
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200515
Country
Romania
Facility Name
Investigational Site
City
Bucharest
ZIP/Postal Code
030303
Country
Romania
Facility Name
Investigational Site
City
Iasi
ZIP/Postal Code
700115
Country
Romania
Facility Name
Investigational Site
City
Moscow
ZIP/Postal Code
109240
Country
Russian Federation
Facility Name
Investigational Site
City
St. Petersburg
ZIP/Postal Code
196247
Country
Russian Federation
Facility Name
Investigational Site
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Investigational Site
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Investigational Site
City
Barcelona
ZIP/Postal Code
08304
Country
Spain
Facility Name
Investigational Site
City
Dnipropetrovsk
ZIP/Postal Code
49059
Country
Ukraine
Facility Name
Investigational Site
City
Ivano-Frankivsik
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Investigational Site
City
Kharkiv
ZIP/Postal Code
61115
Country
Ukraine
Facility Name
Investigational Site
City
Kyiv
ZIP/Postal Code
03680
Country
Ukraine
Facility Name
Investigational Site
City
Zaporizhzhya
ZIP/Postal Code
69035
Country
Ukraine

12. IPD Sharing Statement

Links:
URL
http://www.cerexa.com
Description
Related Info

Learn more about this trial

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

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