Randomized Noninferiority Trial of Cefoperazone-Sulbactam versus Cefepime in the Treatment of Hospital-Acquired and Healthcare-Associated Pneumonia

doi:10.1128/AAC.00023-19

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標題:	Randomized Noninferiority Trial of Cefoperazone-Sulbactam versus Cefepime in the Treatment of Hospital-Acquired and Healthcare-Associated Pneumonia
作者:	Liu, Jien-Wei Chen, Yen-Hsu Lee, Wen-Sen Lin, Jung-Chung Huang, Ching-Tai Lin, Hsi-Hsun Liu, Yung-Ching Chuang, Yin-Ching Hung-Jen Tang(湯宏仁) Chen, Yao-Shen Ko, Wen-Chien Lu, Min-Chi Wang, Fu-Der
貢獻者:	Kaohsiung Chang Gung Mem Hosp, Dept Internal Med, Div Infect Dis Chang Gung Univ, Coll Med Kaohsiung Med Univ Hosp, Dept Internal Med, Div Infect Dis Kaohsiung Med Univ, Coll Med Wan Fang Med Ctr, Dept Internal Med, Div Infect Dis Taipei Med Univ, Sch Med, Dept Internal Med Triserv Gen Hosp, Natl Def Med Ctr, Dept Internal Med, Div Infect Dis & Trop Med Chang Gung Mem Hosp, Dept Internal Med, Div Infect Dis I Shou Univ, E Da Hosp, Dept Internal Med Taipei Med Univ, Shuang Ho Hosp, Div Infect Dis Chi Mei Hosp, Dept Internal Med Chi Mei Med Ctr, Dept Med Chia Nan Univ Pharm & Sci, Dept Hlth & Nutr Natl Yang Ming Univ, Sch Med Kaohsiung Vet Gen Hosp, Dept Internal Med Natl Cheng Kung Univ Hosp, Dept Internal Med Natl Cheng Kung Univ, Coll Med Chung Shan Med Univ Hosp, Dept Internal Med, Div Infect Dis Chung Shan Med Univ, Sch Med, Dept Microbiol & Immunol Taipei Vet Gen Hosp, Dept Med, Div Infect Dis China Med Univ Hosp China Med Univ, Sch Med, Dept Microbiol & Immunol
關鍵字:	cefoperazone-sulbactam cefepime healthcare-associated pneumonia hospital-acquired pneumonia noninferiority trial
日期:	2019-08
上傳時間:	2020-07-29 13:49:03 (UTC+8)
出版者:	AMER SOC MICROBIOLOGY
摘要:	Cefoperazone, a third-generation cephamycin with broad-spectrum antibacterial activity and the ability to permeate bacterial cell membranes, is active against commonly encountered multidrug-resistant pathogens for hospital-acquired pneumonia (HAP) and health care-associated pneumonia (HCAP). To clarify the clinical effects of cefoperazone-sulbactam in the treatment of HAP and HCAP, we conducted an open label, randomized, noninferiority trial that recruited patients aged >= 18 years suffering HAP/HCAP. Participants were randomly assigned to the cefoperazone-sulbactam (2g of each per 12 h) or cefepime (2g per 12 h) arm. Clinical and microbiological responses were evaluated at early posttherapy and test-of-cure visits. Recruited patients were allocated to subpopulations for intent-to-treat (n = 154), per-protocol (n = 147), and safety (n = 166) analyses. Intent-to-treat analysis demonstrated that (i) at the early posttherapy visit, 87.3% of patients receiving cefoperazone-sulbactam and 84.3% of patients receiving cefepime achieved clinical improvement or cure (risk difference of 3.0%; 95% confidence interval [CI], -9.0% to 15.0%), and (ii) at the test-of-cure visit, 73.1% of patients receiving cefoperazonesulbactam and 56.8% of patients receiving cefepime were assessed as cured (risk difference of 16.3%; 95% CI, 0.0% to 33.0%). These results indicated the noninferiority of cefoperazone-sulbactam to cefepime, which was confirmed by per-protocol analysis. The chest radiographic consolidation/infiltration resolution rate, microbiological eradiation rate, and percentage of adverse events were comparable in both groups. Serious adverse events were rare, and none was judged to be related to the study drugs. Cefoperazone-sulbactam at 2 g every 12 h was noninferior to cefepime at 2 g every 2 h for patients with HCAP.
關聯:	Antimicrobial Agents and Chemotherapy, v.63, n.8, e00023-19
顯示於類別:	[保健營養系(所) ] 期刊論文

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