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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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

Study Description

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.

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	848 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, 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
Study Start Date :	December 2011
Actual Primary Completion Date :	May 2013
Actual Study Completion Date :	May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Drug Information available for: Ceftriaxone Ceftriaxone sodium Ceftaroline Ceftaroline fosamil

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

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 ]
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 ]
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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 150 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01371838

Locations

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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, China
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, India
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, Korea, Republic of
Taiwan
Research Site
Kaohsiung, Taiwan
Research Site
Keelung, Taiwan
Research Site
Taichung, Taiwan
Research Site
Taipei, Taiwan
Vietnam
Research Site
Can Tho, Vietnam
Research Site
Hanoi, Vietnam
Research Site
Ho Chi Minh, Vietnam
Research Site
Hochiminh, Vietnam

Sponsors and Collaborators

Pfizer

Forest Laboratories

Investigators

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Study Director:	David Melnick	AstraZeneca

More Information

Additional Information:

D3720C00002 CSR Synopsis This link exits the ClinicalTrials.gov site

Revised CSP This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Zhuo C, Huang Y, Liu W, Xu JF, Zhu WY, Stone GG, Yan JL, Mohamed N. Efficacy and Safety of Ceftaroline Fosamil in Hospitalized Patients with Community-Acquired Pneumonia in China: Subset Analysis of an International Phase 3 Randomized Controlled Trial. Infect Drug Resist. 2022 Feb 23;15:605-617. doi: 10.2147/IDR.S342558. eCollection 2022.

Dryden M, Kantecki M, Yan JL, Stone GG, Leister-Tebbe H, Wilcox M. Treatment outcomes of secondary bacteraemia in patients treated with ceftaroline fosamil: pooled results from six phase III clinical trials. J Glob Antimicrob Resist. 2021 Dec 16;28:108-114. doi: 10.1016/j.jgar.2021.10.027. [Epub ahead of print]

Li J, Das S, Zhou D, Al-Huniti N. Population Pharmacokinetic Modeling and Probability of Target Attainment Analyses in Asian Patients With Community-Acquired Pneumonia Treated With Ceftaroline Fosamil. Clin Pharmacol Drug Dev. 2019 Jul;8(5):682-694. doi: 10.1002/cpdd.673. Epub 2019 May 1.

Cheng K, Pypstra R, Yan JL, Hammond J. Summary of the safety and tolerability of two treatment regimens of ceftaroline fosamil: 600 mg every 8 h versus 600 mg every 12 h. J Antimicrob Chemother. 2019 Apr 1;74(4):1086-1091. doi: 10.1093/jac/dky519.

Das S, Li J, Iaconis J, Zhou D, Stone GG, Yan JL, Melnick D. Ceftaroline fosamil doses and breakpoints for Staphylococcus aureus in complicated skin and soft tissue infections. J Antimicrob Chemother. 2019 Feb 1;74(2):425-431. doi: 10.1093/jac/dky439.

Taboada M, Melnick D, Iaconis JP, Sun F, Zhong NS, File TM, Llorens L, Friedland HD, Wilson D. Ceftaroline fosamil versus ceftriaxone for the treatment of community-acquired pneumonia: individual patient data meta-analysis of randomized controlled trials. J Antimicrob Chemother. 2016 Apr;71(4):862-70. doi: 10.1093/jac/dkv415. Epub 2015 Dec 24. Review. Erratum in: J Antimicrob Chemother. 2016 Jun;71(6):1748-9.

Zhong NS, Sun T, Zhuo C, D'Souza G, Lee SH, Lan NH, Chiang CH, Wilson D, Sun F, Iaconis J, Melnick D. Ceftaroline fosamil versus ceftriaxone for the treatment of Asian patients with community-acquired pneumonia: a randomised, controlled, double-blind, phase 3, non-inferiority with nested superiority trial. Lancet Infect Dis. 2015 Feb;15(2):161-71. doi: 10.1016/S1473-3099(14)71018-7. Epub 2014 Dec 22.

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Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01371838
Other Study ID Numbers:	D3720C00002
First Posted:	June 13, 2011 Key Record Dates
Results First Posted:	September 23, 2014
Last Update Posted:	September 6, 2017
Last Verified:	September 2017

Keywords provided by Pfizer:


Community-Acquired Bacterial Pneumonia

Additional relevant MeSH terms:

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Pneumonia Pneumonia, Bacterial Respiratory Tract Infections Infections Lung Diseases Respiratory Tract Diseases	Bacterial Infections Bacterial Infections and Mycoses Ceftriaxone Ceftaroline fosamil Anti-Bacterial Agents Anti-Infective Agents

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