Phase 3
N=606
Comparative Study of Ceftaroline vs. Ceftriaxone in Adult Subjects With Community-Acquired Pneumonia
Bacterial Pneumonia
Bottom Line
View on ClinicalTrials.gov: NCT00621504 ↗Enrolled (actual)
606
Serious AEs
10.1%
Results posted
Nov 2010
Primary outcome: Primary: Clinical Cure Rate at Test-of-Cure (TOC) in the Modified Intent-to-Treat Efficacy (MITTE) Populations — 244; 233; 34; 58 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ceftaroline fosamil for Injection (Drug); IV Ceftriaxone (Drug); Placebo (Drug); Clarithromycin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Forest Laboratories
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Cure Rate at Test-of-Cure (TOC) in the Modified Intent-to-Treat Efficacy (MITTE) Populations |
244; 233; 34; 58; 13; 9 | — |
| PRIMARY Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test-of-Cure (TOC) in the Clinically Evaluable (CE) Population |
— | — |
| SECONDARY Clinical Response at End of Therapy (EOT) |
— | — |
| SECONDARY Microbiological Success Rate at Test of Cure (TOC) |
— | — |
| SECONDARY Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) |
— | — |
| SECONDARY Clinical and Microbiological Response by Pathogen at TOC |
— | — |
| SECONDARY Clinical Relapse at Late Follow Up (LFU) |
— | — |
| SECONDARY Microbiological Re-infection/Recurrence at LFU |
— | — |
| SECONDARY Evaluate Safety |
— | — |
Summary
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia
Eligibility Criteria
Inclusion Criteria
Subjects are required to meet the following inclusion criteria:
- Community-acquired pneumonia
- initial hospitalization, or treatment in an emergency room or urgent care setting
- infection would require initial treatment with IV antimicrobials.
Exclusion Criteria
Subjects must NOT meet any of the following exclusion criteria:
- CAP suitable for outpatient therapy with an oral antimicrobial agent
- respiratory tract infections not due to community-acquired bacterial
- Non-infectious causes of pulmonary infiltrates
- Pleural empyema
- Infection with an atypical organism
- History of any hypersensitivity or allergic reaction to any ß-lactam antimicrobial
- History of any hypersensitivity or allergic reaction to clarithromycin or any macrolide/ ketolide
Data sourced from ClinicalTrials.gov (NCT00621504). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.