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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00509106
Other study ID # P903-09
Secondary ID
Status Completed
Phase Phase 3
First received July 27, 2007
Last updated November 9, 2010
Start date July 2007
Est. completion date June 2009
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Clinical Trial 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.


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.


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Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

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Sponsors (1)

Lead Sponsor Collaborator
Forest Laboratories

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Bulgaria,  Chile,  Germany,  Hungary,  India,  Latvia,  Mexico,  Peru,  Poland,  Romania,  Russian Federation,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 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
8-15 days after last dose of study drug No
Primary Clinical 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 No
Secondary Clinical Response at End of Therapy (EOT) Last day of study drug administration No
Secondary Microbiological Success Rate at TOC 8-15 days after last dose of study drug No
Secondary Overall Clinical and Radiographic Success Rate at TOC 8-15 days after last dose of study drug No
Secondary Clinical and Micriobiological Response by Pathogen at TOC 8-15 days after last dose of study drug No
Secondary Clinical Relapse at Late Follow Up (LFU) Visit 21-35 days after last dose of study drug No
Secondary Microbiological Reinfection/Recurrence at LFU 21 to 35 days after last dose of study drug No
Secondary Evaluate Safety first dose, throughout the treatment period, and up to the TOC visit Yes
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