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
1 other identifier
interventional
848
5 countries
43
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2011
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2011
CompletedFirst Posted
Study publicly available on registry
June 13, 2011
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedResults Posted
Study results publicly available
September 23, 2014
CompletedSeptember 6, 2017
September 1, 2017
1.4 years
April 27, 2011
May 28, 2014
September 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (15)
Clinical Response at End of Treatment (EOT) Visit in MITT Population
Last day of study drug administration
Clinical Response at End of Treatment (EOT) Visit in CE Population
Last day of study drug administration
Clinical Response at the Test of Cure (TOC) Visit in MITT Population
7-20 days after last day of study drug administration
Clinical Response at the Test of Cure (TOC) Visit in mMITT Population
7-20 days after last day of study drug administration
Clinical Response at the Test of Cure (TOC) Visit in ME Population
7-20 days after last day of study drug administration
- +10 more secondary outcomes
Study Arms (2)
Ceftaroline
EXPERIMENTALCeftriaxone plus placebo
ACTIVE COMPARATORInterventions
One dose infusion followed by IV saline placebo infused q24h for 5 to 7 days plus two consecutive saline placebo infusion q24h.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Forest Laboratoriescollaborator
Study Sites (43)
Research Site
Beijing, China
Research Site
Chengdu, China
Research Site
Guangzhou, 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
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
Research Site
Anyang-si, South Korea
Research Site
Bucheon-si, South Korea
Research Site
Cheonan-si, South Korea
Research Site
Chuncheon, South Korea
Research Site
Daegu, South Korea
Research Site
Daejeon, South Korea
Research Site
Incheon, South Korea
Research Site
Seoul, South Korea
Research Site
Suwon, South Korea
Research Site
Wŏnju, South Korea
Research Site
Kaohsiung City, Taiwan
Research Site
Keelung, Taiwan
Research Site
Taichung, Taiwan
Research Site
Taipei, Taiwan
Research Site
Can Tho, Vietnam
Research Site
Hanoi, Vietnam
Research Site
Ho Chi Minh City, Vietnam
Research Site
Hochiminh, Vietnam
Related Publications (7)
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.
PMID: 35237053DERIVEDDryden 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. 2022 Mar;28:108-114. doi: 10.1016/j.jgar.2021.10.027. Epub 2021 Dec 16.
PMID: 34922058DERIVEDLi 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.
PMID: 31044546DERIVEDCheng 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.
PMID: 30597021DERIVEDDas 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.
PMID: 30380060DERIVEDTaboada 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.
PMID: 26702925DERIVEDZhong 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.
PMID: 25539586DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Melnick, David A / Exec Dir Med Science
- Organization
- AstraZeneca Pharmaceuticals
Study Officials
- STUDY DIRECTOR
David Melnick
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2011
First Posted
June 13, 2011
Study Start
December 1, 2011
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
September 6, 2017
Results First Posted
September 23, 2014
Record last verified: 2017-09