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: September 22, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Community-Acquired Bacterial Pneumonia
Lung Infection of Individual Not Recently Hospitalized
Drug: Ceftaroline
Drug: Ceftriaxone
Phase 3

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Clinical Response at End of Treatment (EOT) Visit in MITT Population [ Time Frame: Last day of study drug administration ] [ Designated as safety issue: No ]
  • Clinical Response at End of Treatment (EOT) Visit in CE Population [ Time Frame: Last day of study drug administration ] [ Designated as safety issue: No ]
  • Clinical Response at the Test of Cure (TOC) Visit in MITT Population [ Time Frame: 7-20 days after last day of study drug administration ] [ Designated as safety issue: No ]
  • Clinical Response at the Test of Cure (TOC) Visit in mMITT Population [ Time Frame: 7-20 days after last day of study drug administration ] [ Designated as safety issue: No ]
  • Clinical Response at the Test of Cure (TOC) Visit in ME Population [ Time Frame: 7-20 days after last day of study drug administration ] [ Designated as safety issue: No ]
  • Clinical Response at Test of Cure (TOC) Visit by Pathogen in ME Population [ Time Frame: 7-20 days after last dose of study drug ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Microbiological Re-infection/Recurrence at LFU Visit in mMITT Population [ Time Frame: 21-42 days after last dose of study drug ] [ Designated as safety issue: No ]
  • Microbiological Re-infection/Recurrence at LFU Visit in ME Population [ Time Frame: 21-42 days after last dose of study drug ] [ Designated as safety issue: No ]

Enrollment: 848
Study Start Date: December 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ceftaroline Drug: Ceftaroline
Two consecutive infusions q12h for 5 to 7 days
Active Comparator: Ceftriaxone plus placebo Drug: Ceftriaxone
One dose infusion followed by IV saline placebo infused q24h for 5 to 7 days plus two consecutive saline placebo infusion q24h.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01371838

  Show 43 Study Locations
Sponsors and Collaborators
AstraZeneca
Forest Laboratories
Investigators
Study Director: David Melnick AstraZeneca
  More Information

Additional Information:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01371838     History of Changes
Other Study ID Numbers: D3720C00002
Study First Received: April 27, 2011
Results First Received: May 28, 2014
Last Updated: September 22, 2014
Health Authority: China: Food and Drug Administration
India: Drugs Controller General of India
South Korea: Korea Food and Drug Administration (KFDA)
Taiwan: Department of Health
Philippines: Bureau of Food and Drugs
Vietnam: Ministry of Health

Keywords provided by AstraZeneca:
Community-Acquired Bacterial Pneumonia

Additional relevant MeSH terms:
Pneumonia, Bacterial
Pneumonia
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Ceftriaxone
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014