Comparative Study of Ceftaroline vs. Ceftriaxone in Adult Subjects With Community-Acquired Pneumonia
- Conditions
- Bacterial Pneumonia
- Interventions
- Registration Number
- NCT00621504
- Lead Sponsor
- Forest Laboratories
- Brief Summary
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia
- Detailed 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 606
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.
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IV Ceftriaxone IV 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). 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. 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). 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. 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). 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. IV Ceftriaxone Clarithromycin 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. Ceftaroline fosamil for Injection Clarithromycin 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.
- Primary Outcome Measures
Name Time Method Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test-of-Cure (TOC) in the Clinically Evaluable (CE) Population 8-15 days after last dose of study drug Clinical Cure Rate at Test-of-Cure (TOC) in the Modified Intent-to-Treat Efficacy (MITTE) Populations 8 to 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 outcome
- Secondary Outcome Measures
Name Time Method Microbiological Success Rate at Test of Cure (TOC) 8-15 days after last dose of study drug Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) 8-15 days after last day of study drug Clinical Response at End of Therapy (EOT) Last day of study drug administration Evaluate Safety first dose, throughout the treatment period, and up to the TOC visit Clinical and Microbiological Response by Pathogen at TOC 8-15 days after last dose of study drug Clinical Relapse at Late Follow Up (LFU) 21-35 days after last dose of study drug Microbiological Re-infection/Recurrence at LFU 21 to 35 days after last dose of study drug
Trial Locations
- Locations (7)
Slovakia
🇸🇰Nitra-Zobor, Slovakia
Investigational site
🇧🇷Porto Alegre, Brazil
Investigational Site 1
🇧🇷Belo Horizonte MG, Brazil
Investigational Site 2
🇧🇷Belo Horizonte, Brazil
InvestigationalSite
🇹🇭Bangkok, Thailand
Investigational Site
🇺🇦Uzhorod, Ukraine
Inestigational Site
🇺🇦Kyiv, Ukraine