ceftaroline
DrugTwo consecutive infusions q12h for 5 to 7 days
NCT Number: NCT01371838
This purpose of this study is to Evaluate the Efficacy and Safety of Intravenous Ceftaroline Versus Intravenous Ceftriaxone in the Treatment of Adult Hospitalised Patients With Community-Acquired Bacterial Pneumonia in Asia.
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Notify Me18 year–150 year
All sexes
Interventional
Phase 3
Research Site, Beijing, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Two consecutive infusions q12h for 5 to 7 days
One dose infusion followed by IV saline placebo infused q24h for 5 to 7 days plus two consecutive saline placebo infusion q24h.
Time frame: 7-20 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 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
Time frame: Last day of study drug administration
Time frame: Last day of study drug administration
Time frame: 7-20 days after last day of study drug administration
Time frame: 7-20 days after last day of study drug administration
Time frame: 7-20 days after last day of study drug administration
Time frame: 7-20 days after last dose of study drug
Time frame: 7-20 days after last dose of study drug
Time frame: 7-20 days after last day of study drug administration
An outcome is considered as favourable if the per-pathogen response for that subject is either Eradication (An adequate source specimen demonstrates absence of the original baseline pathogen) or presumed eradication (An adequate source specimen was not available to culture and the patient was assessed as a clinical cure). Here, an adequate source specimen is defined as any sample that may yield the growth of a CABP pathogen eg, blood, respiratory specimens, or pleural fluid.
Time frame: 7-20 days after last day of study drug administration
An outcome is considered as favourable if the per-pathogen response for that subject is either Eradication (An adequate source specimen demonstrates absence of the original baseline pathogen) or presumed eradication (An adequate source specimen was not available to culture and the patient was assessed as a clinical cure). Here, an adequate source specimen is defined as any sample that may yield the growth of a CABP pathogen eg, blood, respiratory specimens, or pleural fluid.
Time frame: 7-20 days after last day of study drug administration
Time frame: 7-20 days after last dose of study drug
Time frame: 21-42 days after last day of study drug administration
Time frame: 21-42 days after last day of study drug administration
Time frame: 21-42 days after last dose of study drug
Time frame: 21-42 days after last dose of study drug
Pfizer
Industry
A Phase III, Multicentre, Randomised, Double-Blind, Comparative Study to Evaluate the Efficacy and Safety of Intravenous Ceftaroline Versus Intravenous Ceftriaxone in the Treatment of Adult Hospitalised Patients With Community-Acquired Bacterial Pneumonia in Asia
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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