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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 Hospitalised Patients With Community-Acquired Bacterial Pneumonia in Asia
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.
Details
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 848 |
| Start date | 2011-12 |
| Completion | 2013-05 |
Conditions
- Community-Acquired Bacterial Pneumonia
- Lung Infection of Individual Not Recently Hospitalized
Interventions
- Ceftaroline
- Ceftriaxone
Primary outcomes
- Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test of Cure (TOC) in CE Population — 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
Countries
China, India, South Korea, Taiwan, Vietnam