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

This study has been completed.
Sponsor:
Information provided by:
Cerexa, Inc.
ClinicalTrials.gov Identifier:
NCT00509106
First received: July 27, 2007
Last updated: November 9, 2010
Last verified: November 2010
  Purpose

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 Intervention Phase
Bacterial Pneumonia
Drug: Ceftaroline fosamil for Injection
Drug: Ceftriaxone
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Cerexa, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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 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


  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Response at End of Therapy (EOT) [ Time Frame: Last day of study drug administration ] [ Designated as safety issue: No ]
  • Microbiological Success Rate at TOC [ Time Frame: 8-15 days after last dose of study drug ] [ Designated as safety issue: No ]
  • Overall Clinical and Radiographic Success Rate at TOC [ Time Frame: 8-15 days after last dose of study drug ] [ Designated as safety issue: No ]
  • Clinical and Micriobiological Response by Pathogen at TOC [ Time Frame: 8-15 days after last dose of study drug ] [ Designated as safety issue: No ]
  • Clinical Relapse at Late Follow Up (LFU) Visit [ Time Frame: 21-35 days after last dose of study drug ] [ Designated as safety issue: No ]
  • Microbiological Reinfection/Recurrence at LFU [ Time Frame: 21 to 35 days after last dose of study drug ] [ Designated as safety issue: No ]
  • Evaluate Safety [ Time Frame: first dose, throughout the treatment period, and up to the TOC visit ] [ Designated as safety issue: Yes ]

Enrollment: 622
Study Start Date: July 2007
Study Completion Date: June 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00509106

  Show 135 Study Locations
Sponsors and Collaborators
Cerexa, Inc.
Investigators
Principal Investigator: IM Hoepelman, MD UMC Utrecht
  More Information

No publications provided by Cerexa, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vice President, Clinical Sciences, Cerexa, Inc
ClinicalTrials.gov Identifier: NCT00509106     History of Changes
Other Study ID Numbers: P903-09
Study First Received: July 27, 2007
Results First Received: October 12, 2010
Last Updated: November 9, 2010
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Argentina: Human Research Bioethics Committee
Chile: Comisión Nacional de Investigación Científica y Tecnológica
Chile: Instituto de Salud Pública de Chile
Peru: Ethics Committee
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Peru: Ministry of Health
Mexico: Ethics Committee
Mexico: Ministry of Health
Mexico: Federal Commission for Protection Against Health Risks
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: Ministry of Health
Austria: Agency for Health and Food Safety
Austria: Ethikkommission
Hungary: National Institute of Pharmacy
Ukraine: Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Romania: National Medicines Agency
Romania: State Institute for Drug Control
Bulgaria: Bulgarian Drug Agency
Bulgaria: Ministry of Health

Keywords provided by Cerexa, Inc.:
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, Bacterial
Pneumonia
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Ceftriaxone
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014