Comparative Study of Ceftaroline vs. Ceftriaxone in Adult Subjects With Community-Acquired Pneumonia - Full Text View

Sponsored by:	Cerexa, Inc.
Information provided by:	Cerexa, Inc.
ClinicalTrials.gov Identifier:	NCT00621504

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 Drug: ceftriaxone	Phase III

MedlinePlus related topics: Pneumonia

Drug Information available for: Ceftriaxone Ceftriaxone Sodium Clarithromycin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Cerexa, Inc.:

Primary Outcome Measures:

Determine the non-inferiority of ceftaroline compared to that for ceftriaxone in adult subjects with community-acquired pneumonia (CAP) [ Time Frame: Test-of-Cure (TOC) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate the clinical response [ Time Frame: End-of-Therapy (EOT) and TOC visits ] [ Designated as safety issue: No ]
Evaluate the microbiological success rate [ Time Frame: TOC visit ] [ Designated as safety issue: No ]
Evaluate the clinical and microbiological response by pathogen [ Time Frame: TOC visit ] [ Designated as safety issue: No ]
Evaluate clinical relapse [ Time Frame: Late Follow-up (LFU) visit ] [ Designated as safety issue: No ]
Evaluate microbiological re-infection/recurrence [ Time Frame: LFU visit ] [ 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 ]

Estimated Enrollment:	610
Study Start Date:	December 2007
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: ceftaroline 2 consecutive, 300 mg dose parenteral infused over 30 minutes, every 12 hours, for 5 to 7 days
B: Active Comparator	Drug: ceftriaxone 1 g dose parenteral infused over 30 minutes, every 24 hours, for 5 to 7 days

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

Responsible Party:	Cerexa ( Senior Vice President, Clinical Development )
Study ID Numbers:	P903-08
Study First Received:	February 11, 2008
Last Updated:	December 30, 2008
ClinicalTrials.gov Identifier:	NCT00621504
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 and Social Development 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
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

Study placed in the following topic categories:

Bacterial Infections
Lactams
Pneumonia, Mycoplasma
Mycoplasmal pneumonia
Haemophilus influenzae
Mycoplasma Infections
Ceftriaxone
Pleuropneumonia

Clarithromycin
Respiratory Tract Diseases
Respiratory Tract Infections
Pneumonia, Bacterial
Lung Diseases
Beta-Lactams
Influenza, Human
Pneumonia

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009