Comparative Study of Ceftaroline vs. Ceftriaxone in Adults With Community-Acquired Pneumonia

Study Overview
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Brief Summary
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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.

Detailed Description
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Clinical trials is being held in different countries. 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.

Official Title
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A Phase 3, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline Versus Ceftriaxone in the Treatment of Adult Subjects With Community-Acquired Pneumonia

Conditions
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Bacterial Pneumonia

Intervention / Treatment
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* Drug: Ceftaroline fosamil for Injection
* Drug: Ceftriaxone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ceftaroline fosamil for injection<br>Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h). | Drug: Ceftaroline fosamil for Injection<br>* 2 consecutive, 300 mg dose parenteral infused over 30 minutes, every 12 hours for 5 to 7 days<br>* Other names: Experimental;|
| Active Comparator: IV Ceftriaxone<br>Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h). | Drug: Ceftriaxone<br>* 1 g dose parenteral infused over 30 minutes, every 24 hours for 5 to 7 days<br>* Other names: Active comparator;Drug: Placebo<br>* Subjects randomized to receive ceftriaxone will receive ceftriaxone at a dose of 1 g infused over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h). Twelve hours after each dose of ceftriaxone and saline placebo (ie, between ceftriaxone doses), subjects in this group will receive two consecutive saline placebo infusions, each infused over 30 minutes q24h. The ceftriaxone and saline placebo infusions will correspond to the q12h infusions of ceftaroline, thereby maintaining the blind<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 adverse event (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 | 8-15 days after last dose of study drug | 
| Clinical Cure Rate for Ceftaroline Compared With That for Ceftriaxone at TOC in the Clinically Evaluable (CE) Population |  | 8-15 days after last dose of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Response at End of Therapy (EOT) |  | Last day of study drug administration | 
| Microbiological Success Rate at TOC |  | 8-15 days after last dose of study drug | 
| Overall Clinical and Radiographic Success Rate at TOC |  | 8-15 days after last dose of study drug | 
| Clinical and Microbiological Response by Pathogen at TOC |  | 8-15 days after last dose of study drug | 
| Clinical Relapse at Late Follow Up (LFU) Visit |  | 21-35 days after last dose of study drug | 
| Microbiological Reinfection/Recurrence at LFU |  | 21 to 35 days after last dose of study drug | 
| Evaluate Safety |  | first dose, throughout the treatment period, and up to the TOC visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CAP, ceftaroline, Community-acquired pneumonia, Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, Chlamydophila spp, Legionella ssp, multi-drug resistant Streptococcus pneumoniae (MDRSP), antimicrobial resistance, pneumococci, beta-lactam, ceftaroline fosamil, ceftriaxone, antibiotic