This purpose of this study is to Evaluate the Efficacy and Safety of Intravenous Ceftaroline Versus Intravenous Ceftriaxone in the Treatment of Adult Hospitalised Patients With Community-Acquired Bacterial Pneumonia in Asia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
848
Two consecutive infusions q12h for 5 to 7 days
One dose infusion followed by IV saline placebo infused q24h for 5 to 7 days plus two consecutive saline placebo infusion q24h.
Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test of Cure (TOC) in CE Population
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
Time frame: 7-20 days after last dose of study drug
Clinical Response at End of Treatment (EOT) Visit in MITT Population
Time frame: Last day of study drug administration
Clinical Response at End of Treatment (EOT) Visit in CE Population
Time frame: Last day of study drug administration
Clinical Response at the Test of Cure (TOC) Visit in MITT Population
Time frame: 7-20 days after last day of study drug administration
Clinical Response at the Test of Cure (TOC) Visit in mMITT Population
Time frame: 7-20 days after last day of study drug administration
Clinical Response at the Test of Cure (TOC) Visit in ME Population
Time frame: 7-20 days after last day of study drug administration
Clinical Response at Test of Cure (TOC) Visit by Pathogen in ME Population
Time frame: 7-20 days after last dose of study drug
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Research Site
Beijing, China
Research Site
Chengdu, China
Research Site
Guangzhou, China
Research Site
Haikou, China
Research Site
Hangzhou, China
Research Site
Hefei, China
Research Site
Jiangyin, China
Research Site
Nanchang, China
Research Site
Shanghai, China
Research Site
Shenyang, China
...and 33 more locations
Per-Pathogen Microbiological Response at Test of Cure (TOC) Visit by Pathogen in ME Population
Time frame: 7-20 days after last dose of study drug
Per-Patient Microbiological Response at Test of Cure (TOC) Visit in mMITT Population
An outcome is considered as favourable if the per-pathogen response for that subject is either Eradication (An adequate source specimen demonstrates absence of the original baseline pathogen) or presumed eradication (An adequate source specimen was not available to culture and the patient was assessed as a clinical cure). Here, an adequate source specimen is defined as any sample that may yield the growth of a CABP pathogen eg, blood, respiratory specimens, or pleural fluid.
Time frame: 7-20 days after last day of study drug administration
Per-Patient Microbiological Response at Test of Cure (TOC) Visit in ME Population
An outcome is considered as favourable if the per-pathogen response for that subject is either Eradication (An adequate source specimen demonstrates absence of the original baseline pathogen) or presumed eradication (An adequate source specimen was not available to culture and the patient was assessed as a clinical cure). Here, an adequate source specimen is defined as any sample that may yield the growth of a CABP pathogen eg, blood, respiratory specimens, or pleural fluid.
Time frame: 7-20 days after last day of study drug administration
Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) Visit in MITT Population
Time frame: 7-20 days after last day of study drug administration
Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) Visit in CE Population
Time frame: 7-20 days after last dose of study drug
Clinical Relapse at the LFU Visit for Clinical Cure Patients at Test of Cure (TOC) Visit in MITT Population
Time frame: 21-42 days after last day of study drug administration
Clinical Relapse at the LFU Visit for Clinical Cure Patients at Test of Cure (TOC) Visit in CE Population
Time frame: 21-42 days after last day of study drug administration
Microbiological Re-infection/Recurrence at LFU Visit in mMITT Population
Time frame: 21-42 days after last dose of study drug
Microbiological Re-infection/Recurrence at LFU Visit in ME Population
Time frame: 21-42 days after last dose of study drug