A 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

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01371838
First received: April 27, 2011
Last updated: April 15, 2014
Last verified: April 2014

April 27, 2011
April 15, 2014
December 2011
May 2013   (final data collection date for primary outcome measure)
To determine the non-inferiority in clinical cure rate of ceftaroline treatment compared with that of ceftriazone treatment at Test-of-cure visit in Clinical evaluable population. [ Time Frame: The duration of treatment with study drug is 5-7 days. Clinical cure rate will be assessed 8-15 days after the last dose of study drug. ] [ Designated as safety issue: No ]
To determine the non-feriority in clinical cure rate of ceftaroline treatment compared with that of ceftriazone treatment at Test-of-cure visit in Clinical evaluabe population. [ Time Frame: The duration of treatment with study drug is 5-7 days. Clinical cure rate will be assessed 8-15 days after the last dose of study drug. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01371838 on ClinicalTrials.gov Archive Site
  • Efficacy of ceftaroline by clinical response, overall( combined clinical and radiographic response) and microbiological response [ Time Frame: The duration of treatment with study drug is 5-7 days. Patient participation will require between 26-42 days. ] [ Designated as safety issue: No ]
  • Safety of ceftaroline by adverse event, Electrocardiogram , Laboratory assessments, Physical examinations, Vital signs [ Time Frame: The duration of treatment with study drug is 5-7 days. Patient participation will require between 26-42 days. ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A 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
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Community-Acquired Bacterial Pneumonia
  • Lung Infection of Individual Not Recently Hospitalized
  • Drug: Ceftaroline
    Two consecutive infusions q12h for 5 to 7 days
  • Drug: Ceftriaxone
    One dose infusion followed by IV saline placebo infused q24h for 5 to 7 days plus two consecutive saline placebo infusion q24h.
  • Experimental: Ceftaroline
    Intervention: Drug: Ceftaroline
  • Active Comparator: Ceftriaxone plus placebo
    Intervention: Drug: Ceftriaxone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1225
May 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males and females 18 or more years of age
  • Lung Infection of Individual not Recently Hospitalized meeting the following criteria: Radiographically-confirmed pneumonia (new or progressive infection site of the lungs) consistent with bacterial pneumonia), AND Acute illness (≤ 7 days duration) with at least three of the following clinical signs or symptoms consistent with lung infection: New or increased cough, Purulent sputum or change in sputum character, Auscultatory findings consistent with pneumonia, Difficulty in breathing, short breath, or decreased partial pressure of oxygen in blood, Fever greater than 38ºC oral or body temperature lower than that required for normal body function(< 35ºC), White blood cell count greater than or less than the normal, Greater than 15% immature neutrophils (bands) irrespective of white blood cell count, AND Moderate lung infection
  • The subject must require initial hospitalization, or treatment in an emergency room or urgent care setting, by the standard of care
  • The subject's infection would require initial treatment with intravenous antimicrobials
  • Female subjects of child-bearing potential, and those who are fewer than 2 years post-menopausal, must agree to, and comply with, using highly effective methods of birth control while participating in this study

Exclusion Criteria:

  • Lung Infection of Individual not Recently Hospitalized suitable for outpatient therapy with an oral antimicrobial agent
  • Confirmed or suspected respiratory tract infections attributable to sources other than bacteria from the individuals not recently hospitalized(e.g., ventilator-associated pneumonia, hospital-acquired pneumonia, visible/gross aspiration pneumonia, suspected viral, fungal, or mycobacterial infection of the lung)
  • Non-infectious causes of lung lesion (e.g., pulmonary embolism, chemical pneumonitis from aspiration, hypersensitivity pneumonia, congestive heart failure)
  • Accumulation of pus in the pleural cavity
  • Microbiologically-documented infection with a pathogen known to be resistant to ceftriaxone, or epidemiological or clinical context suggesting high likelihood of a ceftriaxone-resistant "typical" bacterial pathogen.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China,   India,   Korea, Republic of,   Taiwan,   Vietnam
 
NCT01371838
D3720C00002
Not Provided
AstraZeneca
AstraZeneca
Forest Laboratories
Study Director: David Melnick AstraZeneca
AstraZeneca
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP