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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

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
Research Site
Beijing, , China
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Community-Acquired Bacterial Pneumonia, Lung Infection of Individual Not Recently Hospitalized
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-150 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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( 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01371838
Pfizer
Completed
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

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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
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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
848
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.
Sexes Eligible for Study: All
18 Years to 150 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China,   India,   Korea, Republic of,   Taiwan,   Vietnam
Philippines
 
NCT01371838
D3720C00002
Not Provided
Not Provided
Not Provided
Pfizer
Pfizer
Forest Laboratories
Study Director: David Melnick AstraZeneca
Pfizer
September 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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