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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cerexa, Inc.
ClinicalTrials.gov Identifier:
NCT00621504
First received: February 11, 2008
Last updated: September 20, 2011
Last verified: September 2011
History of Changes
  Purpose

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia


Condition Intervention Phase
Bacterial Pneumonia
 Drug: Ceftaroline fosamil for Injection
Drug: IV Ceftriaxone
Drug: Placebo
Drug: Clarithromycin
 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, With Adjunctive Clarithromycin, in the Treatment of Adult Subjects With Community-Acquired Pneumonia

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Further study details as provided by Cerexa, Inc.:

Primary Outcome Measures:
  • Clinical Cure Rate at Test-of-Cure (TOC) in the Modified Intent-to-Treat Efficacy (MITTE) Populations [ Time Frame: 8 to 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 to That for Ceftriaxone at Test-of-Cure (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 Test of Cure (TOC) [ Time Frame: 8-15 days after last dose of study drug ] [ Designated as safety issue: No ]
  • Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) [ Time Frame: 8-15 days after last day of study drug ] [ Designated as safety issue: No ]
  • Clinical and Microbiological 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) [ Time Frame: 21-35 days after last dose of study drug ] [ Designated as safety issue: No ]
  • Microbiological Re-infection/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: 606
Study Start Date: January 2008
Study Completion Date: June 2009
Primary Completion Date: December 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).

In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.

 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: Ceftaroline fosamil for injection
Drug: Clarithromycin
In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.
Other Name: Clarithromycin
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).

In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.

 Drug: IV Ceftriaxone
1 g dose parenteral infused over 30 minutes, every 24 hours, for 5 to 7 days
Other Name: Ceftriaxone
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
Drug: Clarithromycin
In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.
Other Name: Clarithromycin

Detailed Description:

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia. Clinical trials for this study is held in many countries

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects are required to meet the following inclusion criteria:

  • Community-acquired pneumonia
  • initial hospitalization, or treatment in an emergency room or urgent care setting
  • infection would require initial treatment with IV antimicrobials.

Exclusion Criteria:

Subjects must NOT meet any of the following exclusion criteria:

  • CAP suitable for outpatient therapy with an oral antimicrobial agent
  • respiratory tract infections not due to community-acquired bacterial
  • Non-infectious causes of pulmonary infiltrates
  • Pleural empyema
  • Infection with an atypical organism
  • History of any hypersensitivity or allergic reaction to any ß-lactam antimicrobial
  • History of any hypersensitivity or allergic reaction to clarithromycin or any macrolide/ ketolide
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00621504

  Show 168 Study Locations
Sponsors and Collaborators
Cerexa, Inc.
Investigators
Study Director: Thomas M File, MD, MS Summa Health System
  More Information

No publications provided by Cerexa, Inc.

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

Responsible Party: Cerexa, Inc.
ClinicalTrials.gov Identifier: NCT00621504     History of Changes
Other Study ID Numbers: P903-08
Study First Received: February 11, 2008
Results First Received: October 12, 2010
Last Updated: September 20, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Hong Kong: Department of Health
Hong Kong: Ethics Committee
Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
Malaysia: Ministry of Health
Thailand: Ethical Committee
Thailand: Food and Drug Administration
Thailand: Khon Kaen University Ethics Committee for Human Research
Thailand: Ministry of Public Health
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Argentina: Human Research Bioethics Committee
Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Russia: Pharmacological Committee, Ministry of Health
Ukraine: Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health
Lithuania: Bioethics Committee
Lithuania: State Medicine Control Agency - Ministry of Health
Bulgaria: Bulgarian Drug Agency
Bulgaria: Ministry of Health
Romania: Ministry of Public Health
Romania: National Medicines Agency

Keywords provided by Cerexa, Inc.:
ceftaroline
Community-acquired pneumonia
CAP
IV (intravenous)
Streptococcus pneumoniae
Haemophilus influenzae
Mycoplasma pneumoniae
Chlamydophila spp
Legionella spp
 Multi-drug resistant Streptococcus pneumoniae (MDRSP)
antimicrobial resistance
pneumococci
Ceftriaxone
bacteria
ß-lactam
beta-lactam
antibiotic

Additional relevant MeSH terms:
Pneumonia, Bacterial
Pneumonia
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Ceftriaxone
Clarithromycin
 Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013