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
Chao Zhuo,1 Yijiang Huang,2 Wenyuan Liu,3 Jin-Fu Xu,4 Wei Yun Zhu,5 Gregory G Stone,6 Jean Li Yan,7 Naglaa Mohamed8 1State Key Laboratory of Respiratory Disease, National Clinical Research Center of Respiratory Diseases, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Gua...
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| Format: | Article |
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Dove Medical Press
2022-02-01
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| Series: | Infection and Drug Resistance |
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| Online Access: | https://www.dovepress.com/efficacy-and-safety-of-ceftaroline-fosamil-in-hospitalized-patients-wi-peer-reviewed-fulltext-article-IDR |
| _version_ | 1819280943815327744 |
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| author | Zhuo C Huang Y Liu W Xu JF Zhu WY Stone GG Yan JL Mohamed N |
| author_facet | Zhuo C Huang Y Liu W Xu JF Zhu WY Stone GG Yan JL Mohamed N |
| author_sort | Zhuo C |
| collection | DOAJ |
| description | Chao Zhuo,1 Yijiang Huang,2 Wenyuan Liu,3 Jin-Fu Xu,4 Wei Yun Zhu,5 Gregory G Stone,6 Jean Li Yan,7 Naglaa Mohamed8 1State Key Laboratory of Respiratory Disease, National Clinical Research Center of Respiratory Diseases, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, People’s Republic of China; 2Respiratory Clinical Medical Center, Hainan Cancer Hospital, Hainan, People’s Republic of China; 3Respiratory Department, Sichuan Provincial People’s Hospital, Chengdu, People’s Republic of China; 4Department of Respiratory and Critical Care Medicine, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, People’s Republic of China; 5Medical Department, Pfizer Investment Co. Ltd., Beijing, People’s Republic of China; 6Biopharmaceuticals Group, Pfizer Inc., Groton, CT, USA; 7Biopharmaceuticals Group, Pfizer Inc., Cambridge, MA, USA; 8Biopharmaceuticals Group, Pfizer Inc., New York, NY, USACorrespondence: Chao Zhuo, Email chaosheep@sina.comBackground: Ceftaroline fosamil has demonstrated superior clinical efficacy versus ceftriaxone for hospitalized adults with moderate-to-severe community-acquired pneumonia (CAP) in a Phase 3 trial in Asia and in a meta-analysis of three trials in Asia, North America, and Europe. Efficacy and safety outcomes for the subset of patients in China in the ASIA CAP trial were analyzed to determine if the same conclusions hold in the China subpopulation.Methods: Hospitalized adults with Pneumonia Outcomes Research Team risk class III–IV CAP were randomized (1:1) to receive either intravenous ceftaroline fosamil 600 mg every 12 h or ceftriaxone 2 g every 24 h for 5– 7 days. The primary efficacy variable was clinical response at test-of-cure (TOC) in the clinically evaluable (CE) population. Secondary endpoints included microbiological responses and safety.Results: Of 302 patients randomized in China, 205 were included in the CE population. Clinical cure rates at TOC were 80/105 (76.2%) for ceftaroline fosamil and 61/100 (61.0%) for ceftriaxone (difference 15.2%, 95% CI 2.5, 27.6), thereby meeting predefined non-inferiority and superiority criteria for the overall study. Subgroup analyses of the primary endpoint demonstrated consistency of favourable efficacy of ceftaroline fosamil across age groups, Pneumonia Outcomes Research Team risk classes and CURB-65 scores. Microbiological responses were presumed from clinical outcomes. Adverse events were consistent with the study treatments’ known safety profiles.Conclusion: The China subset results are consistent with the overall study population, despite the smaller sample size. Ceftaroline fosamil was both non-inferior and superior to ceftriaxone for empiric treatment of Chinese patients with moderate-to-severe CAP.Trial Registration: ClinicalTrials.gov identifier NCT01371838.Keywords: ceftriaxone, CURB-65, treatment outcomes, clinical trial |
| first_indexed | 2024-12-24T00:51:50Z |
| format | Article |
| id | doaj.art-15f9ce7f57f84e2abfcf1d6a26003d9a |
| institution | Directory Open Access Journal |
| issn | 1178-6973 |
| language | English |
| last_indexed | 2024-12-24T00:51:50Z |
| publishDate | 2022-02-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Infection and Drug Resistance |
| spelling | doaj.art-15f9ce7f57f84e2abfcf1d6a26003d9a2022-12-21T17:23:34ZengDove Medical PressInfection and Drug Resistance1178-69732022-02-01Volume 1560561773152Efficacy and Safety of Ceftaroline Fosamil in Hospitalized Patients with Community-Acquired Pneumonia in China: Subset Analysis of an International Phase 3 Randomized Controlled TrialZhuo CHuang YLiu WXu JFZhu WYStone GGYan JLMohamed NChao Zhuo,1 Yijiang Huang,2 Wenyuan Liu,3 Jin-Fu Xu,4 Wei Yun Zhu,5 Gregory G Stone,6 Jean Li Yan,7 Naglaa Mohamed8 1State Key Laboratory of Respiratory Disease, National Clinical Research Center of Respiratory Diseases, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, People’s Republic of China; 2Respiratory Clinical Medical Center, Hainan Cancer Hospital, Hainan, People’s Republic of China; 3Respiratory Department, Sichuan Provincial People’s Hospital, Chengdu, People’s Republic of China; 4Department of Respiratory and Critical Care Medicine, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, People’s Republic of China; 5Medical Department, Pfizer Investment Co. Ltd., Beijing, People’s Republic of China; 6Biopharmaceuticals Group, Pfizer Inc., Groton, CT, USA; 7Biopharmaceuticals Group, Pfizer Inc., Cambridge, MA, USA; 8Biopharmaceuticals Group, Pfizer Inc., New York, NY, USACorrespondence: Chao Zhuo, Email chaosheep@sina.comBackground: Ceftaroline fosamil has demonstrated superior clinical efficacy versus ceftriaxone for hospitalized adults with moderate-to-severe community-acquired pneumonia (CAP) in a Phase 3 trial in Asia and in a meta-analysis of three trials in Asia, North America, and Europe. Efficacy and safety outcomes for the subset of patients in China in the ASIA CAP trial were analyzed to determine if the same conclusions hold in the China subpopulation.Methods: Hospitalized adults with Pneumonia Outcomes Research Team risk class III–IV CAP were randomized (1:1) to receive either intravenous ceftaroline fosamil 600 mg every 12 h or ceftriaxone 2 g every 24 h for 5– 7 days. The primary efficacy variable was clinical response at test-of-cure (TOC) in the clinically evaluable (CE) population. Secondary endpoints included microbiological responses and safety.Results: Of 302 patients randomized in China, 205 were included in the CE population. Clinical cure rates at TOC were 80/105 (76.2%) for ceftaroline fosamil and 61/100 (61.0%) for ceftriaxone (difference 15.2%, 95% CI 2.5, 27.6), thereby meeting predefined non-inferiority and superiority criteria for the overall study. Subgroup analyses of the primary endpoint demonstrated consistency of favourable efficacy of ceftaroline fosamil across age groups, Pneumonia Outcomes Research Team risk classes and CURB-65 scores. Microbiological responses were presumed from clinical outcomes. Adverse events were consistent with the study treatments’ known safety profiles.Conclusion: The China subset results are consistent with the overall study population, despite the smaller sample size. Ceftaroline fosamil was both non-inferior and superior to ceftriaxone for empiric treatment of Chinese patients with moderate-to-severe CAP.Trial Registration: ClinicalTrials.gov identifier NCT01371838.Keywords: ceftriaxone, CURB-65, treatment outcomes, clinical trialhttps://www.dovepress.com/efficacy-and-safety-of-ceftaroline-fosamil-in-hospitalized-patients-wi-peer-reviewed-fulltext-article-IDRceftriaxonecurb-65treatment outcomesclinical trial |
| spellingShingle | 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 Infection and Drug Resistance ceftriaxone curb-65 treatment outcomes clinical trial |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | ceftriaxone curb-65 treatment outcomes clinical trial |
| url | https://www.dovepress.com/efficacy-and-safety-of-ceftaroline-fosamil-in-hospitalized-patients-wi-peer-reviewed-fulltext-article-IDR |
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