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

Community-Acquired Bacterial Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01371838
• Other study ID #: D3720C00002
• Status: Completed
• Phase: Phase 3
• First received: April 27, 2011
• Last updated: September 1, 2017
• Start date: December 2011
• Est. completion date: May 2013

Study information

• Verified date: September 2017
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 848
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 150 Years

Eligibility

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.

Related Conditions & MeSH terms

• Community-Acquired Bacterial Pneumonia
• Lung Infection of Individual Not Recently Hospitalized
• Pneumonia
• Pneumonia, Bacterial

Intervention

Drug:
• Ceftaroline
Two consecutive infusions q12h for 5 to 7 days
• Ceftriaxone
One dose infusion followed by IV saline placebo infused q24h for 5 to 7 days plus two consecutive saline placebo infusion q24h.

Locations

Country	Name	City	State
China	Research Site	Beijing
China	Research Site	Chengdu
China	Research Site	Guang Zhou
China	Research Site	Haikou
China	Research Site	Hangzhou
China	Research Site	Hefei
China	Research Site	Jiangyin
China	Research Site	Nanchang
China	Research Site	Shanghai
China	Research Site	Shenyang
China	Research Site	Shenzhen
China	Research Site	Shijiazhuang
China	Research Site	Wuxi
India	Research Site	Bangalore
India	Research Site	Calicut
India	Research Site	Goa
India	Research Site	Hyderabad
India	Research Site	Jaipur
India	Research Site	Lucknow
India	Research Site	Ludhiana
India	Research Site	Mysore
India	Research Site	New Delhi
India	Research Site	Trivandrum
India	Research Site	Varanasi
India	Research Site	Vellore
Korea, Republic of	Research Site	Anyang-si
Korea, Republic of	Research Site	Bucheon-si
Korea, Republic of	Research Site	Cheonan-si
Korea, Republic of	Research Site	Chuncheon-si
Korea, Republic of	Research Site	Daegu
Korea, Republic of	Research Site	Daejeon
Korea, Republic of	Research Site	Incheon
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Suwon-si
Korea, Republic of	Research Site	Wonju-si
Taiwan	Research Site	Kaohsiung
Taiwan	Research Site	Keelung
Taiwan	Research Site	Taichung
Taiwan	Research Site	Taipei
Vietnam	Research Site	Can Tho
Vietnam	Research Site	Hanoi
Vietnam	Research Site	Ho Chi Minh
Vietnam	Research Site	Hochiminh

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Forest Laboratories

Countries where clinical trial is conducted

China,  India,  Korea, Republic of,  Taiwan,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test of Cure (TOC) in CE Population	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	7-20 days after last dose of study drug
Secondary	Clinical Response at End of Treatment (EOT) Visit in MITT Population		Last day of study drug administration
Secondary	Clinical Response at End of Treatment (EOT) Visit in CE Population		Last day of study drug administration
Secondary	Clinical Response at the Test of Cure (TOC) Visit in MITT Population		7-20 days after last day of study drug administration
Secondary	Clinical Response at the Test of Cure (TOC) Visit in mMITT Population		7-20 days after last day of study drug administration
Secondary	Clinical Response at the Test of Cure (TOC) Visit in ME Population		7-20 days after last day of study drug administration
Secondary	Clinical Response at Test of Cure (TOC) Visit by Pathogen in ME Population		7-20 days after last dose of study drug
Secondary	Per-Pathogen Microbiological Response at Test of Cure (TOC) Visit by Pathogen in ME Population		7-20 days after last dose of study drug
Secondary	Per-Patient Microbiological Response at Test of Cure (TOC) Visit in mMITT Population	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.	7-20 days after last day of study drug administration
Secondary	Per-Patient Microbiological Response at Test of Cure (TOC) Visit in ME Population	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.	7-20 days after last day of study drug administration
Secondary	Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) Visit in MITT Population		7-20 days after last day of study drug administration
Secondary	Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) Visit in CE Population		7-20 days after last dose of study drug
Secondary	Clinical Relapse at the LFU Visit for Clinical Cure Patients at Test of Cure (TOC) Visit in MITT Population		21-42 days after last day of study drug administration
Secondary	Clinical Relapse at the LFU Visit for Clinical Cure Patients at Test of Cure (TOC) Visit in CE Population		21-42 days after last day of study drug administration
Secondary	Microbiological Re-infection/Recurrence at LFU Visit in mMITT Population		21-42 days after last dose of study drug
Secondary	Microbiological Re-infection/Recurrence at LFU Visit in ME Population		21-42 days after last dose of study drug

External Links

•   D3720C00002 CSR Synopsis
•   Revised CSP