Conditions: Bacterial Pneumonia
Keywords: ceftaroline Community-acquired pneumonia CAP 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
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 622
Healthy volunteers: no

Brief 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.

Detailed 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.

Arms:
arm 1: Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h). arm 2: 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).

Interventions: intervention 1: Ceftaroline fosamil for Injection intervention 2: Ceftriaxone intervention 3: Placebo
Intervention descriptions: intervention 1: 2 consecutive, 300 mg dose parenteral infused over 30 minutes, every 12 hours for 5 to 7 days intervention 2: 1 g dose parenteral infused over 30 minutes, every 24 hours for 5 to 7 days intervention 3: 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

Protocol document: