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

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:

MedlinePlus related topics: Antibiotics Pneumonia

Drug Information available for: Ceftriaxone Ceftriaxone sodium Ceftaroline Ceftaroline fosamil

U.S. FDA Resources

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

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

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):

Shorr AF, Kollef M, Eckburg PB, Llorens L, Friedland HD. Assessment of ceftaroline fosamil in the treatment of community-acquired bacterial pneumonia due to Streptococcus pneumoniae: insights from two randomized trials. Diagn Microbiol Infect Dis. 2013 Mar;75(3):298-303. doi: 10.1016/j.diagmicrobio.2012.12.002. Epub 2013 Jan 26.

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 Publica 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 May 22, 2013

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