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

Forest Laboratories

Status and phase: Completed; Phase 3

Conditions: Bacterial Pneumonia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00621504

P903-08

Details and patient eligibility

About

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia

Full description

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia. Clinical trials for this study is held in many countries

Enrollment: 606 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

606 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). In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.

Treatment:

Drug: Clarithromycin

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). In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.

Treatment:

Drug: IV Ceftriaxone

Drug: Clarithromycin

Drug: Placebo