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, Yijiang Huang, Wenyuan Liu, Jin-Fu Xu, Wei Yun Zhu, Gregory G Stone, Jean Li Yan, Naglaa Mohamed, Chao Zhuo, Yijiang Huang, Wenyuan Liu, Jin-Fu Xu, Wei Yun Zhu, Gregory G Stone, Jean Li Yan, Naglaa Mohamed

Abstract

Background: 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: CURB-65; ceftriaxone; clinical trial; treatment outcomes.

Conflict of interest statement

Chao Zhuo, Yijiang Huang, Wenyuan Liu, and Jin-Fu Xu received institutional research grant funding from AstraZeneca for the conduct of the study. Wei Yun Zhu, Gregory G. Stone, Jean Li Yan and Naglaa Mohamed are employees and share holders of Pfizer. The authors report no other conflicts of interest in this work.

© 2022 Zhuo et al.

Figures

Figure 1
Figure 1
Patient disposition in the China subset.
Figure 2
Figure 2
Subgroup analysis of clinical cure rates at the TOC visit in the China subset (CE population, Excluding Site 1314).

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Source: PubMed

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