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

Forest Laboratories

Status and phase: Completed; Phase 3

Conditions: Bacterial Pneumonia

Treatments: Drug: Placebo; Drug: Ceftriaxone; Drug: Ceftaroline fosamil for Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT00509106

P903-09

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 622 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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622 participants in 2 patient groups

Ceftaroline fosamil for injection

Experimental group

Description:

Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h).

Treatment:

Drug: Ceftaroline fosamil for Injection

IV Ceftriaxone

Active Comparator group

Description:

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).

Treatment:

Drug: Ceftriaxone

Drug: Placebo