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Trial record 1 of 1 for:    NCT01371838
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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01371838
Recruitment Status : Completed
First Posted : June 13, 2011
Results First Posted : September 23, 2014
Last Update Posted : September 6, 2017
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE April 27, 2011
First Posted Date  ICMJE June 13, 2011
Results First Submitted Date  ICMJE May 28, 2014
Results First Posted Date  ICMJE September 23, 2014
Last Update Posted Date September 6, 2017
Study Start Date  ICMJE December 2011
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2014)
Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test of Cure (TOC) in CE Population [ 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
Original Primary Outcome Measures  ICMJE
 (submitted: June 10, 2011)
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. ]
Change History Complete list of historical versions of study NCT01371838 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2014)
  • Clinical Response at End of Treatment (EOT) Visit in MITT Population [ Time Frame: Last day of study drug administration ]
  • Clinical Response at End of Treatment (EOT) Visit in CE Population [ Time Frame: Last day of study drug administration ]
  • Clinical Response at the Test of Cure (TOC) Visit in MITT Population [ Time Frame: 7-20 days after last day of study drug administration ]
  • Clinical Response at the Test of Cure (TOC) Visit in mMITT Population [ Time Frame: 7-20 days after last day of study drug administration ]
  • Clinical Response at the Test of Cure (TOC) Visit in ME Population [ Time Frame: 7-20 days after last day of study drug administration ]
  • Clinical Response at Test of Cure (TOC) Visit by Pathogen in ME Population [ Time Frame: 7-20 days after last dose of study drug ]
  • Per-Pathogen Microbiological Response at Test of Cure (TOC) Visit by Pathogen in ME Population [ Time Frame: 7-20 days after last dose of study drug ]
  • Per-Patient Microbiological Response at Test of Cure (TOC) Visit in mMITT Population [ 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.
  • Per-Patient Microbiological Response at Test of Cure (TOC) Visit in ME Population [ 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.
  • Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) Visit in MITT Population [ Time Frame: 7-20 days after last day of study drug administration ]
  • Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) Visit in CE Population [ Time Frame: 7-20 days after last dose of study drug ]
  • Clinical Relapse at the LFU Visit for Clinical Cure Patients at Test of Cure (TOC) Visit in MITT Population [ Time Frame: 21-42 days after last day of study drug administration ]
  • Clinical Relapse at the LFU Visit for Clinical Cure Patients at Test of Cure (TOC) Visit in CE Population [ Time Frame: 21-42 days after last day of study drug administration ]
  • Microbiological Re-infection/Recurrence at LFU Visit in mMITT Population [ Time Frame: 21-42 days after last dose of study drug ]
  • Microbiological Re-infection/Recurrence at LFU Visit in ME Population [ Time Frame: 21-42 days after last dose of study drug ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2011)
  • 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. ]
  • 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. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Community-Acquired Bacterial Pneumonia
  • Lung Infection of Individual Not Recently Hospitalized
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Ceftaroline
    Intervention: Drug: Ceftaroline
  • Active Comparator: Ceftriaxone plus placebo
    Intervention: Drug: Ceftriaxone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 22, 2014)
848
Original Estimated Enrollment  ICMJE
 (submitted: June 10, 2011)
692
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 150 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China,   India,   Korea, Republic of,   Taiwan,   Vietnam
Removed Location Countries Philippines
 
Administrative Information
NCT Number  ICMJE NCT01371838
Other Study ID Numbers  ICMJE D3720C00002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Forest Laboratories
Investigators  ICMJE
Study Director: David Melnick AstraZeneca
PRS Account Pfizer
Verification Date September 2017

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