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

Sponsor:	Cerexa, Inc.
Information provided by (Responsible Party):	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 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

Drug Information available for: Ceftriaxone Ceftriaxone sodium Clarithromycin Ceftaroline fosamil

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

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

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 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
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

Cephalosporins
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 24, 2012