[Translation] A multicenter, single-arm, open-label, observational study of ceftazidime tazobactam sodium for injection (5:1) in the treatment of moderate to severe acute bacterial infections

评价上市后的注射用头孢他啶他唑巴坦钠（5:1）对治疗中、重度急性细菌性感染的安全性，并收集有效性信息.

[Translation]

To evaluate the safety of post-marketing ceftazidime tazobactam sodium for injection (5:1) in the treatment of moderate to severe acute bacterial infections and to collect efficacy information.

Start Date16 Jul 2014

Sponsor / Collaborator

Hainan Guoruitang Pharmaceutical Co. Ltd.

[+1]

CTR20140530 / Active, not recruitingPhase 4

注射用头孢他啶他唑巴坦钠（5:1）治疗中、重度急性细菌性感染的多中心、单臂、开放性、观察性研究

[Translation] A multicenter, single-arm, open-label, observational study of ceftazidime tazobactam sodium for injection (5:1) in the treatment of moderate to severe acute bacterial infections

评价上市后的注射用头孢他啶他唑巴坦钠（5:1）对治疗中、重度急性细菌性感染的安全性，并收集有效性信息.

[Translation]

To evaluate the safety of post-marketing ceftazidime tazobactam sodium for injection (5:1) in the treatment of moderate to severe acute bacterial infections and to collect efficacy information.

Start Date16 Jul 2014

Sponsor / Collaborator

Hainan Guoruitang Pharmaceutical Co. Ltd.

[+1]

CTR20140296 / RecruitingPhase 4

注射用头孢他啶他唑巴坦钠（3:1）治疗中、重度急性细菌感染的非随机、非对照、多中心、开放性Ⅳ期临床研究

[Translation] A non-randomized, non-controlled, multicenter, open-label phase IV clinical study of ceftazidime tazobactam sodium for injection (3:1) in the treatment of moderate to severe acute bacterial infections

在广泛使用条件下，评价注射用头孢他啶他唑巴坦钠（3:1）治疗中、重度急性细菌感染的安全性和有效性。

[Translation]

To evaluate the safety and efficacy of ceftazidime tazobactam sodium for injection (3:1) in the treatment of moderate to severe acute bacterial infections under widespread use conditions.

Start Date14 Jan 2014

Sponsor / Collaborator

Honz Pharmaceutical Co., Ltd.

100 Clinical Results associated with Ceftazidime/Tazobactam Sodium

100 Translational Medicine associated with Ceftazidime/Tazobactam Sodium

100 Patents (Medical) associated with Ceftazidime/Tazobactam Sodium

Literatures (Medical) associated with Ceftazidime/Tazobactam Sodium

01 Sep 2024·Journal of Global Antimicrobial Resistance

In vitro activity of ceftolozane/tazobactam against Gram-negative bacilli isolated from pediatric patients: Results from the Study for Monitoring Antimicrobial Resistance Trends (SMART) 2017–2021, China

Article

Author: Mu, Xinli ; Yu, Yunsong ; Fu, Ying ; Li, Pengcheng

OBJECTIVESCeftolozane-tazobactam (C/T) is a combination of a cephalosporin and a β-lactamase inhibitor with activity against Gram-negative bacilli (GNB). The study aims were to evaluate the activity of C/T in vitro vs. comparators against clinical GNB isolated from Chinese paediatric patients.METHODSFrom 2017-2021, 660 GNB isolates were collected from 20 hospitals across China. The minimum inhibitory concentrations were tested using a Trek Diagnostic System (Thermo Fisher Scientific). Susceptibility was determined by CLSI broth microdilution and the results were interpreted according to CLSI M100 (2021) breakpoints.RESULTSGNB isolates were obtained from paediatric patients < 18 years old, mainly from the bloodstream (n = 146), intraperitoneal cavity (n = 138), lower respiratory (n = 278) and urinary tract (n = 96). Overall, C/T was active against 76.6% of 436 Enterobacterales, with a descending susceptibility rate of 100.0% to S. marcescens, 92.2% to E. coli, 83.3% to K. oxytoca, 66.7% to K. aerogenes, 66.7% to P. mirabilis, 58.6% to K. pneumoniae and 57.1% to E. cloacae. The susceptibility of P. aeruginosa to C/T was 89.4%, which was the highest among the β-lactam antibiotics and was second only to amikacin (92.9%). Isolates of respiratory tract infection (RTI) derived P. aeruginosa were highly susceptible (93.8%) to C/T, while <75% of isolates of RTI derived P. aeruginosa were susceptible to the other β-lactam antibiotics tested, except for ceftazidime-avibactam (91.2%).CONCLUSIONGNBs collected from paediatric patients in China showed a high susceptibility to C/T making this drug combination an effective choice for treating the paediatric population, especially those infected with P. aeruginosa.

02 May 2024·Journal of Antimicrobial Chemotherapy

Assessing the impact of meropenem exposure on ceftolozane/tazobactam-resistance development in Pseudomonas aeruginosa using in vitro serial passage

Article

Author: Gill, Christian M ; Tamma, Pranita D ; Fouad, Aliaa ; Simner, Patricia J ; Nicolau, Samantha E ; Nicolau, David P

AbstractBackgroundPatients infected with difficult-to-treat Pseudomonas aeruginosa are likely to receive meropenem (MEM) empirically before escalation to ceftolozane/tazobactam (C/T). We assessed whether pre-exposure to MEM affected C/T resistance development on C/T exposure.Materials and methodsNine clinical P. aeruginosa isolates were exposed to MEM 16 mg/L for 72 h. Then, isolates were serially passaged in the presence of C/T (concentration of 10 mg/L) for 72 h as two groups: an MEM-exposed group inoculated with MEM pre-exposed isolates and a non-MEM control group. At 24 h intervals, samples were plated on drug-free and drug-containing agar (C/T concentration 16/8 mg/L) and incubated to quantify bacterial densities (log10 cfu/mL). Growth on C/T agar indicated resistance development, and resistant population was calculated by dividing the cfu/mL on C/T plates by the cfu/mL on drug-free agar.ResultsAt 72 h, resistant populations were detected in 6/9 isolates. In five isolates, MEM exposure significantly increased the prevalence of ceftolozane/tazobactam-resistance development; the percentages of resistance population were 100%, 100%, 53.5%, 31% and 3% for the MEM-exposed versus 0%, 0%, 2%, 0.35% and ≤0.0003% in the unexposed groups. One isolate had a similar resistant population at 72 h between the two groups. The remaining isolates showed no development of resistance, regardless of previous MEM exposure.ConclusionsMEM exposure may pre-dispose to C/T resistance development and thus limit the therapeutic utility of this β-lactam/β-lactamase inhibitor. Resistance may be a result of stress exposure or molecular-level mutations conferring cross-resistance. Further in vivo studies are needed to assess clinical implications of these findings.

01 Mar 2024·Brazilian Journal of Microbiology

Clinical outcomes of intensive care unit patients infected with multidrug-resistant gram-negative bacteria treated with ceftazidime/avibactam and ceftolozane/tazobactam

Article

Author: Neves, Camila Soares ; Moura, Líbia Cristina Rocha Vilela ; Da Costa Lima, Jailton Lobo ; Maciel, Maria Amélia Vieira

In intensive care units (ICUs), infection rates range from 18 to 54%, which is five to ten times higher than those observed in other hospital units, with a mortality rate of 9% to 60%. In recent decades, the susceptibility pattern has changed and Gram-Negative Bacteria (GNB) have become a threat due to their high frequency of multidrug resistance associated with a scarcity of therapeutic options. However, the drugs Ceftolozane/Tazobactam (C/T) and Ceftazidime/Avibactam (C/A) are demonstrating good clinical and microbiological response in the treatment of severe nosocomial infections. Therefore, this study aims to evaluate the clinical outcome of patients with severe infections caused by Multidrug-Resistant (MDR) GNB treated with C/T and C/A. Our study evaluates a total of 131 patients who received treatment with C/T and C/A due to infections caused by MDR GNB within the period from 2018 to 2021. The main infections were urinary tract (46,6%) and respiratory (26,7%) infections. Pseudomonas aeruginosa was the prevailing agent in the sample evaluation (34.3%), followed by Klebsiella pneumoniae (30,1%). About 54,9% of patients showed a favorable response, with culture negativation in 66,4% of the samples, with no discrepancy in negativations when comparing ages: 67,7% in young and 66% in elderly patients. Among the patients, 62,6% received monotherapy with C/T and C/A with a better response observed with monotherapy compared to combination therapy (58,6% vs 41,4%). The overall mortality rate was 45%, with MDR GNB infections responsible for 33,9% of these deaths, and the others (66,1%) due to factors such as oncological, hematological, and degenerative neurological diseases. In regards to hematological aspect, 35,1% of patients showed changes, with 28,2% of them presenting anemia, 4,5% thrombocytopenia, and 2,5% thrombocytosis. Concerning the use of invasive devices, higher mortality was observed in patients on mechanical ventilation (52%). In this manner, it was possible to observe that therapy with C/T and C/A yielded a favorable clinical outcome in patients with severe infections caused by MDR GNB in the study. These drugs also demonstrated good tolerability regardless of age or the presence of preexisting comorbidities and were deemed safe when assessing adverse effects. Our data also demonstrate the importance of determining the mechanism of resistance to carbapenems so that these drugs can be used more effectively and rationally.

100 Deals associated with Ceftazidime/Tazobactam Sodium

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Infectious Diseases	CN	Chongqing Kerui Pharmaceutical Co. Ltd.	01 Nov 2010

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Genitourinary tract infection	Phase 2	CN	Xiangbei Welman Pharmaceutical Co., Ltd.	09 Feb 2012
Respiratory Tract Infections	Phase 2	CN	Xiangbei Welman Pharmaceutical Co., Ltd.	09 Feb 2012

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