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Comparative Study of Ceftaroline vs. Ceftriaxone in Adults With Community-Acquired Pneumonia (CAP)

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ClinicalTrials.gov Identifier: NCT00509106
Recruitment Status : Completed
First Posted : July 31, 2007
Results First Posted : November 8, 2010
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

Brief Summary:
The purpose of the study is to determine if the antibiotic ceftaroline is safe and effective in the treatment of community-acquired pneumonia in adults.

Condition or disease Intervention/treatment Phase
Bacterial Pneumonia Drug: Ceftaroline fosamil for Injection Drug: Ceftriaxone Drug: Placebo Phase 3

Detailed Description:
Clinical trials is being held in different countries. The purpose of the study is to determine if the antibiotic ceftaroline is safe and effective in the treatment of community-acquired pneumonia in adults.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 622 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline Versus Ceftriaxone in the Treatment of Adult Subjects With Community-Acquired Pneumonia
Study Start Date : July 2007
Primary Completion Date : August 2008
Study Completion Date : June 2009


Arm Intervention/treatment
Experimental: Ceftaroline fosamil for injection
Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h).
Drug: Ceftaroline fosamil for Injection
2 consecutive, 300 mg dose parenteral infused over 30 minutes, every 12 hours for 5 to 7 days
Other Name: Experimental
Active Comparator: IV Ceftriaxone
Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
Drug: Ceftriaxone
1 g dose parenteral infused over 30 minutes, every 24 hours for 5 to 7 days
Other Name: Active comparator
Drug: Placebo
Subjects randomized to receive ceftriaxone will receive ceftriaxone at a dose of 1 g infused over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h). Twelve hours after each dose of ceftriaxone and saline placebo (ie, between ceftriaxone doses), subjects in this group will receive two consecutive saline placebo infusions, each infused over 30 minutes q24h. The ceftriaxone and saline placebo infusions will correspond to the q12h infusions of ceftaroline, thereby maintaining the blind



Primary Outcome Measures :
  1. Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at the Test of Cure (TOC) in the Modified Intent to Treat Efficacy (MITTE) Population [ Time Frame: 8-15 days after last dose of study drug ]

    Cure:Total resolution of all signs and symptoms of pneumonia (ie,CABP), or improvement to such an extent that further antimicrobial therapy was not necessary

    Failure: Any of the following:

    • Persistence, incomplete clinical resolution, or worsening in signs and symptoms of CABP that required alternative antimicrobial therapy
    • Treatment-limiting adverse event (AE) leading to discontinuation of study drug therapy, when subject required alternative antimicrobial therapy to treat the pneumonia
    • Death wherein pneumonia (ie,CABP) was considered causative

    Indeterminate: Inability to determine an outcome


  2. Clinical Cure Rate for Ceftaroline Compared With That for Ceftriaxone at TOC in the Clinically Evaluable (CE) Population [ Time Frame: 8-15 days after last dose of study drug ]

Secondary Outcome Measures :
  1. Clinical Response at End of Therapy (EOT) [ Time Frame: Last day of study drug administration ]
  2. Microbiological Success Rate at TOC [ Time Frame: 8-15 days after last dose of study drug ]
  3. Overall Clinical and Radiographic Success Rate at TOC [ Time Frame: 8-15 days after last dose of study drug ]
  4. Clinical and Microbiological Response by Pathogen at TOC [ Time Frame: 8-15 days after last dose of study drug ]
  5. Clinical Relapse at Late Follow Up (LFU) Visit [ Time Frame: 21-35 days after last dose of study drug ]
  6. Microbiological Reinfection/Recurrence at LFU [ Time Frame: 21 to 35 days after last dose of study drug ]
  7. Evaluate Safety [ Time Frame: first dose, throughout the treatment period, and up to the TOC visit ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects with community-acquired pneumonia requiring:

  • initial hospitalization or treatment in an emergency room or urgent care setting
  • infection requiring initial treatment with IV antimicrobial

Exclusion Criteria:

  • Community-acquired pneumonia suitable for outpatient therapy with an oral antimicrobial agent
  • Respiratory tract infections not due to community-acquired bacterial pathogens
  • Infections resistant to ceftriaxone
  • Any condition requiring concomitant systemic corticosteroids
  • History of any hypersensitivity or allergic reaction to any ß-lactam antimicrobial

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): NCT00509106


  Show 135 Study Locations
Sponsors and Collaborators
Forest Laboratories
Investigators
Principal Investigator: IM Hoepelman, MD UMC Utrecht

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00509106     History of Changes
Other Study ID Numbers: P903-09
First Posted: July 31, 2007    Key Record Dates
Results First Posted: November 8, 2010
Last Update Posted: March 14, 2017
Last Verified: February 2017

Keywords provided by Forest Laboratories:
ceftaroline
Community-acquired pneumonia
CAP
Streptococcus pneumoniae
Haemophilus influenzae
Mycoplasma pneumoniae
Chlamydophila spp
Legionella ssp
multi-drug resistant Streptococcus pneumoniae (MDRSP)
antimicrobial resistance
pneumococci
beta-lactam
ceftaroline fosamil
ceftriaxone
antibiotic

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Bacterial
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bacterial Infections
Ceftriaxone
Cephalosporins
Anti-Bacterial Agents
Anti-Infective Agents