A phase III, multicenter, double-blind, randomized clinical trial to evaluate the efficacy and safety of ceftolozane/tazobactam plus metronidazole versus meropenem in Chinese participants with complicated intra-abdominal infections

Sun, Yihong; Fan, Jia; Chen, Gang; Chen, Xiaofei; Du, Xiaoling; Wang, Ye; Wang, Hui; Sun, Fang; Johnson, Matthew G.; Bensaci, Mekki; Huntington, Jennifer A.; Bruno, Christopher

doi:10.1016/j.ijid.2022.08.003

Cited by 9 publications

(3 citation statements)

References 23 publications

(21 reference statements)

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“…2,30–32,46–48 Based on several randomized clinical trials conducted in recent years, Ceftolozane/Tazobactam has been found to be comparable to meropenem as an effective and safe treatment option for complicated and life-threatening infections caused by ESBL-producing Enterobacterales. 49–55 Ceftolozane/Tazobactam may confer a survival advantage over meropenem in invasive ESBLs-related infections, leading to lower mortality. 52,54 However, this effect needs confirmation through adequately powered prospective studies.…”

Section: Discussionmentioning

confidence: 99%

Global evaluation of the antibacterial activity of Ceftolozane/Tazobactam against ESBLs-producing Escherichia coli and Klebsiella pneumoniae: a systematic review and meta-analysis

Rahim Khorasani,

Rostami,

Bakhshi

et al. 2023

Therapeutic Advances in Infection

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Background: Ceftolozane/Tazobactam is a β-lactam/β-lactamase inhibitor combination with a high range of efficacy and broad-spectrum action against multidrug-resistant bacterial strains. Objectives: The present study aimed to analyze the in vitro activity of Ceftolozane/Tazobactam against extended-spectrum β-lactamases (ESBLs)-producing Escherichia coli (ESBLs-EC) and Klebsiella pneumonia (ESBLs-KP) in the published literature to provide international data on the antimicrobial stewardship programs. Design: Systematic review and meta-analysis. Methods: A systematic literature search was conducted on the Web of Science, Embase, PubMed, Scopus, and Google Scholar electronic databases from the beginning of databases to December 2022 to cover all published articles relevant to our scope. Results: At last, 31 publications that met our inclusion criteria were selected for data extraction and analysis by Comprehensive Meta-Analysis Software. The pooled prevalence of Ceftolozane/Tazobactam susceptibility for ESBLs-EC and ESBLs-KP was estimated at 91.3% [95% confidence interval (CI): 90.1–92.5%] and 65.6% (95% CI: 60.8–70.2%), respectively. There was significant heterogeneity among the 31 studies for ESBLs-EC (χ2 = 91.621; p < 0.001; I2 = 67.256%) and ESBLs-KP (χ2 = 348.72; p < 0.001; I2 = 91.4%). Most clinical isolates of ESBLs-EC had MIC50 and MIC90 at a concentration of 0.5 and 2 µg/mL [minimum inhibitory concentration (MIC) at which 50% and 90% of isolates were inhibited], respectively. In contrast, most clinical isolates of ESBLs-KP had MIC50 and MIC90 at a concentration of 1 and 32 µg/mL, respectively. Conclusion: Based on the meta-analysis results, Ceftolozane/Tazobactam has a more promising in vitro antibacterial activity against ESBLs-EC isolates from different clinical sources than ESBLs-KP isolates. Therefore, Ceftolozane/Tazobactam can be a useful therapeutic drug as an alternative to carbapenems. Randomized clinical trials are needed to provide clinical evidence to support these observations.

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Section: Discussionmentioning

confidence: 99%

Global evaluation of the antibacterial activity of Ceftolozane/Tazobactam against ESBLs-producing Escherichia coli and Klebsiella pneumoniae: a systematic review and meta-analysis

Rahim Khorasani,

Rostami,

Bakhshi

et al. 2023

Therapeutic Advances in Infection

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“…In ASPECT-cIAI, ceftolozane/tazobactam was non-inferior for the primary endpoint of clinical cure, with rates of 83.0% (n = 323/389) and 87.3% (n = 364/417) for ceftolozane/tazobactam plus metronidazole and 87.3% (n = 364/417) for meropenem [ 45 ]. Efficacy of ceftolozane/tazobactam for the treatment of cIAI has also been confirmed in Asian participants [ 48 , 49 ]. One phase III study by Sun et al demonstrated non-inferiority of ceftolozane/tazobactam plus metronidazole versus meropenem in adult Chinese participants (N = 268), with clinical cure rates of 95.2% and 93.1%, respectively [ 48 ].…”

Section: Clinical Studies In Patients Treated With Ceftolozane/tazoba...mentioning

confidence: 99%

“…Efficacy of ceftolozane/tazobactam for the treatment of cIAI has also been confirmed in Asian participants [ 48 , 49 ]. One phase III study by Sun et al demonstrated non-inferiority of ceftolozane/tazobactam plus metronidazole versus meropenem in adult Chinese participants (N = 268), with clinical cure rates of 95.2% and 93.1%, respectively [ 48 ].…”

Section: Clinical Studies In Patients Treated With Ceftolozane/tazoba...mentioning

confidence: 99%

Perspectives on the use of ceftolozane/tazobactam: a review of clinical trial data and real-world evidence

Martin-Loeches,

Bruno,

DeRyke

2024

Future Microbiology

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Hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) are common healthcare-associated infections linked to high morbidity and mortality. Gram-negative pathogens, such as Pseudomonas aeruginosa, exhibit multidrug resistance and are recognized as major public health concerns, particularly among critically ill patients with HABP/VABP. Ceftolozane/tazobactam is a novel combination antibacterial agent comprising ceftolozane (a potent antipseudomonal cephalosporin) and tazobactam (a β-lactamase inhibitor). Phase III trials have demonstrated non-inferiority of ceftolozane/tazobactam to comparators, leading to the approval of ceftolozane/tazobactam for the treatment of complicated urinary tract infections, complicated intra-abdominal infections, and nosocomial pneumonia. In this article, we review the clinical trial evidence and key real-world effectiveness data of ceftolozane/tazobactam for the treatment of serious healthcare-associated Gram-negative infections, focusing on patients with HABP/VABP.

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Effectiveness of novel β-lactams for Pseudomonas aeruginosa infection: A systematic review and meta-analysis

Huang,

Cai,

Liu

et al. 2024

American Journal of Infection Control

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A phase III, multicenter, double-blind, randomized clinical trial to evaluate the efficacy and safety of ceftolozane/tazobactam plus metronidazole versus meropenem in Chinese participants with complicated intra-abdominal infections

Cited by 9 publications

References 23 publications

Global evaluation of the antibacterial activity of Ceftolozane/Tazobactam against ESBLs-producing Escherichia coli and Klebsiella pneumoniae: a systematic review and meta-analysis

Global evaluation of the antibacterial activity of Ceftolozane/Tazobactam against ESBLs-producing Escherichia coli and Klebsiella pneumoniae: a systematic review and meta-analysis

Perspectives on the use of ceftolozane/tazobactam: a review of clinical trial data and real-world evidence

Effectiveness of novel β-lactams for Pseudomonas aeruginosa infection: A systematic review and meta-analysis

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