The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
606
2 consecutive, 300 mg dose parenteral infused over 30 minutes, every 12 hours, for 5 to 7 days
1 g dose parenteral infused over 30 minutes, every 24 hours, for 5 to 7 days
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
Clinical Cure Rate at Test-of-Cure (TOC) in the Modified Intent-to-Treat Efficacy (MITTE) Populations
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 adverse event (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
Time frame: 8 to 15 days after last dose of study drug
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
Clinical Response at End of Therapy (EOT)
Time frame: Last day of study drug administration
Microbiological Success Rate at Test of Cure (TOC)
Time frame: 8-15 days after last dose of study drug
Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC)
Time frame: 8-15 days after last day of study drug
Clinical and Microbiological Response by Pathogen at TOC
Time frame: 8-15 days after last dose of study drug
Clinical Relapse at Late Follow Up (LFU)
Time frame: 21-35 days after last dose of study drug
Microbiological Re-infection/Recurrence at LFU
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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.
Investigational site
Los Angeles, California, United States
Investigational Site
Pasadena, California, United States
Investigational Site
Sacramento, California, United States
Investigational Site
San Diego, California, United States
Investigational Site
Orlando, Florida, United States
Investigational Site
Fort Gordon, Georgia, United States
Investigational Site
Peoria, Illinois, United States
Investigational Site
Baltimore, Maryland, United States
Investigational site
Minneapolis, Minnesota, United States
Investigational Site
Butte, Montana, United States
...and 158 more locations
Time frame: 21 to 35 days after last dose of study drug
Evaluate Safety
Time frame: first dose, throughout the treatment period, and up to the TOC visit