Comparative Study of Ceftaroline vs. Ceftriaxone in Adults With Community-Acquired Pneumonia
- Conditions
- Bacterial Pneumonia
- Interventions
- Registration Number
- NCT00509106
- Lead Sponsor
- Forest Laboratories
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 622
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ceftaroline fosamil for injection Ceftaroline fosamil for Injection Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h). IV Ceftriaxone Ceftriaxone 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). IV Ceftriaxone Placebo 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).
- Primary Outcome Measures
Name Time Method 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 8-15 days after last dose of study drug 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 outcomeClinical 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
Name Time Method Clinical and Microbiological Response by Pathogen at TOC 8-15 days after last dose of study drug 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 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
Trial Locations
- Locations (8)
Inestigational Site
🇵🇱Warszawa, Poland
Investigational site
🇺🇦Kyiv, Ukraine
Investigtional Site
🇵🇱Krakow, Poland
Invetigational Site
🇦🇷Buenos Aires, Argentina
Investigational Site
🇺🇦Zhytomyr, Ukraine
Investigational Drug
🇧🇬Varna, Bulgaria
INvestigational Site
🇦🇷Cordoba, Argentina
Investigator Site
🇵🇱Bialystok, Poland