Clinical Trial: A Study 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 Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase III, Multicentre, Randomised, Double-Blind, Comparative Study to Evaluate the Efficacy and Safety of Intravenous Ceftaroline Versus Intravenous Ceftriaxone in the Treatment of Adult Hospitalis

Brief Summary: 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.

Detailed Summary:
Sponsor: AstraZeneca

Current Primary Outcome: Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test of Cure (TOC) in CE Population [ Time Frame: 7-20 days after last dose of study drug ]

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


Original Primary Outcome: To determine the non-feriority in clinical cure rate of ceftaroline treatment compared with that of ceftriazone treatment at Test-of-cure visit in Clinical evaluabe population. [ Time Frame: The duration of treatment with study drug is 5-7 days. Clinical cure rate will be assessed 8-15 days after the last dose of study drug. ]

Current Secondary Outcome:

  • 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 ]
  • 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 [ Time Frame: 7-20 days after last day of study drug administration ]
    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.
  • Per-Patient Microbiological Response at Test of Cure (TOC) Visit in ME Population [ Time Frame: 7-20 days after last day of study drug administration ]
    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.
  • 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 ]


Original Secondary Outcome:

  • Efficacy of ceftaroline by clinical response, overall( combined clinical and radiographic response) and microbiological response [ Time Frame: The duration of treatment with study drug is 5-7 days. Patient participation will require between 26-42 days. ]
  • Safety of ceftaroline by adverse event, Electrocardiogram , Laboratory assessments, Physical examinations, Vital signs [ Time Frame: The duration of treatment with study drug is 5-7 days. Patient participation will require between 26-42 days. ]


Information By: AstraZeneca

Dates:
Date Received: April 27, 2011
Date Started: December 2011
Date Completion:
Last Updated: November 28, 2014
Last Verified: November 2014