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
NCT01371838
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- 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
- 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.
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Descriptive Information | ||||
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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 |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* 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 | 848 | |||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |