Phase 3
Completed N=622
Comparative Study of Ceftaroline vs. Ceftriaxone in Adults With Community-Acquired Pneumonia
Source: ClinicalTrials.gov NCT00509106 ↗Enrolled (actual)
622
Serious AEs
12.9%
Results posted
Nov 2010
Primary outcomePrimary: Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at the Test of Cure (TOC) in the Modified Intent to Treat Efficacy (MITTE) Population — 235; 206; 47; 56 participants
Summary
The purpose of the study is to determine if the antibiotic ceftaroline is safe and effective in the treatment of community-acquired pneumonia in adults.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at the Test of Cure (TOC) in the Modified Intent to Treat Efficacy (MITTE) Population |
235; 206; 47; 56; 7; 11 | — |
| PRIMARY Clinical Cure Rate for Ceftaroline Compared With That for Ceftriaxone at TOC in the Clinically Evaluable (CE) Population |
— | — |
| SECONDARY Clinical Response at End of Therapy (EOT) |
— | — |
| SECONDARY Microbiological Success Rate at TOC |
— | — |
| SECONDARY Overall Clinical and Radiographic Success Rate at TOC |
— | — |
| SECONDARY Clinical and Microbiological Response by Pathogen at TOC |
— | — |
| SECONDARY Clinical Relapse at Late Follow Up (LFU) Visit |
— | — |
| SECONDARY Microbiological Reinfection/Recurrence at LFU |
— | — |
| SECONDARY Evaluate Safety |
— | — |
Eligibility Criteria
Inclusion Criteria
Subjects with community-acquired pneumonia requiring:
- initial hospitalization or treatment in an emergency room or urgent care setting
- infection requiring initial treatment with IV antimicrobial
Exclusion Criteria
- Community-acquired pneumonia suitable for outpatient therapy with an oral antimicrobial agent
- Respiratory tract infections not due to community-acquired bacterial pathogens
- Infections resistant to ceftriaxone
- Any condition requiring concomitant systemic corticosteroids
- History of any hypersensitivity or allergic reaction to any ß-lactam antimicrobial
Data sourced from ClinicalTrials.gov (NCT00509106). 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. Informational only — not medical advice.