Evaluate the effectiveness of mono therapy with piperacillin/tazobactam and multiple drugs therapy for the treatment of perforated appendix in children: ( from 4 years till 13 years) A randomised control trial.

开始日期2023-12-25

申办/合作机构-

NCT05981079

/ Recruiting临床4期IIT

Model-based Dose Versus Empirical Dose of Piperacillin/Tazobactam in the Treatment of Late-onset Sepsis in Preterm Neonates: a Multicentre, Randomised, Open-label, Non-inferiority Study.

This study aims to compare the clinical outcomes, safety and PD target attainment of the model-based dose and empirical dose of piperacillin/tazobactam in the treatment of LOS in premature neonates, so as to optimize the piperacillin/tazobactam dose regimen.

开始日期2023-07-31

申办/合作机构

山东大学

[+4]

TCTR20220515001

/ CompletedN/AIIT

Population pharmacokinetics and Monte Carlo dosing simulations of intravenous piperacillin/tazobactam in patients on continuous ambulatory peritoneal dialysis with peritonitis

开始日期2021-04-01

申办/合作机构-

100 项与地塞米松/哌拉西林/他唑巴坦相关的临床结果

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100 项与地塞米松/哌拉西林/他唑巴坦相关的转化医学

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100 项与地塞米松/哌拉西林/他唑巴坦相关的专利（医药）

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项与地塞米松/哌拉西林/他唑巴坦相关的文献（医药）

2024-12-01·International Journal of Infectious Diseases

A phase III randomized controlled non-inferiority trial to study the efficacy and safety of imipenem/cilastatin/relebactam (IMI/REL) versus piperacillin/tazobactam (PIP/TAZ) in patients with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP)

Article

作者: Zhu, Mingfen ; Iamboliyska, Zlatka ; Xiang, Peng ; Zhou, Min ; Chen, Chang ; Chen, Luke Francis ; Young, Katherine ; Ding, Lianshu ; Wei, Feng ; Koseoglu, Sandra ; Sun, Fang ; Tang, Zhengang ; Li, Junjie ; Du, Xiaoling ; Bruno, Christopher ; Losada, Maria ; Qu, Jieming ; Guo, Xiaodan

OBJECTIVESImipenem/cilastatin/relebactam (IMI/REL) is a β-lactam/β-lactamase inhibitor combination effective against gram-negative pathogens. Efficacy and safety of IMI/REL were studied in critically ill adults with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP).METHODSIn this phase III, double-blind, multinational, randomized trial (NCT03583333), adults with HABP/VABP were randomized 1:1 to receive intravenous IMI/REL (500 mg/250 mg) or piperacillin/tazobactam (PIP/TAZ; 4000 mg/500 mg) every 6 h for 7-14 days. The primary endpoint was 28-day all-cause mortality (ACM). Secondary endpoints were clinical response (CR), microbiological response (MR), and adverse event (AE) incidence.RESULTSIn the modified intention-to-treat population (N = 270 [IMI/REL: n = 134; PIP/TAZ: n = 136]), demographics and baseline characteristics were comparable between treatment groups. Most patients were from China. IMI/REL was non-inferior to PIP/TAZ for 28-day ACM (11.2% vs 5.9%; adjusted difference [95% confidence interval]: 5.2% [-1.5 to 12.4]). Secondary outcomes were comparable between treatment groups, including favorable CR and MR. AEs resulting in death were generally consistent with pre-existing or underlying illness.CONCLUSIONSIMI/REL met non-inferiority criteria versus PIP/TAZ for 28-day ACM, and safety profiles were comparable. This trial could support the use of IMI/REL to treat adults with HABP/VABP, including regional use in China.

2024-08-01·Journal of Infection and Public Health

Evaluation of antimicrobial selective pressure using the multicenter semiautomatic surveillance system Japan surveillance for infection prevention and healthcare epidemiology

Article

作者: Kawabata, Jun ; Ishioka, Haruhiko ; Matsunaga, Nobuaki ; Tsuzuki, Shinya ; Fujii, Naoki ; Fukuda, Haruhisa ; Tajima, Taichi ; Sakaguchi, Mikiyo ; Endo, Mio ; Asai, Yusuke ; Ohmagari, Norio ; Hayakawa, Kayoko

BACKGROUNDEvaluating the selective pressure of antimicrobials on bacteria is important for promoting antimicrobial stewardship programs (ASPs). The aim of this study was to assess the selective pressure of antimicrobials by evaluating their use (carbapenem [CBP] and CBP-sparing therapy) over time and the detection status of CBP-resistant organisms using multicenter data.METHODSAmong the facilities whose data were registered in the Japan Surveillance for Infection Prevention and Healthcare Epidemiology from 2017 to 2020, those that had data on the use of CBP and CBP-sparing therapy (fluoroquinolones [FQs], cefmetazole [CMZ], piperacillin-tazobactam [PIP/TAZ], ampicillin-sulbactam [ABPC/SBT], ceftriaxone/cefotaxime [CTRX/CTX], CAZ (ceftazidime), cefepime [CFPM], and aminoglycosides [AGs]) as well as on CBP-resistant Enterobacterales (CRE) and CBP-resistant Pseudomonas aeruginosa (CRPA) detection were included. Alcohol-based hand rubbing (ABHR) usage was also analyzed. Regression analyses, including multivariable regression analysis, were performed to evaluate trends. The association of antimicrobial use density (AUD) with CRE and CRPA detection rates was evaluated.RESULTSIn 28 facilities nationwide, CBP, FQ, CAZ, AG, and PIP/TAZ use decreased over the 3-year period, whereas the use of CMZ, ABPC/SBT, CTRX/CTX, CFPM, and ABHR as well as the rates of CRE and CRPA detection increased. The average AUD did not significantly correlate with CRE and CRPA detection rates. The multivariable regression analysis did not reveal any significant correlation between each AUD or ABHR and CRE or CRPA detection.CONCLUSIONCBP and ABHR use showed a decreasing and an increasing trend, respectively, while CRPA and CRE detection rates exhibited a gradual increase. The considerably low CRE and CRPA detection rates suggest that slight differences in numbers may have been observed as excessive trend changes. Further investigation is warranted to evaluate selective pressure while considering the characteristics of ASP and the mechanisms underlying resistance.

2024-07-19·Alternative therapies in health and medicine

A Promising Candidate in the Treatment of Children with Bronchopneumonia: Erythromycin Plus PIP/TAZ.

Article

作者: Kong, Ting ; Chen, Chunbao ; Wang, Jia

ObjectiveTo investigate the efficacy of piperacillin-tazobactam (PIP/TAZ) versus PIP/TAZ plus erythromycin in the treatment of children with bronchopneumonia, and to evaluate the influence of these treatments on inflammatory factors and intestinal flora. Assessing the impact on these parameters is crucial to provide a comprehensive understanding of the treatment effects.MethodsA total of 120 children with bronchial pneumonia who were treated in Yichang Central People's Hospital from April 2018 to April 2020 were randomized (1:1) either into the control group or the observation group. The control group was given PIP/TAZ treatment. The observation group was additionally treated with erythromycin on the basis of the control group. The clinical efficacy, disappearance time of main symptoms and signs, inflammatory factors, and intestinal flora before and after treatment were compared between the two groups.ResultsThe treatment with PIP/TAZ plus erythromycin led to a significantly higher total clinical effective rate versus PIP/TAZ alone (P < .05). PIP/TAZ plus erythromycin resulted in a shorter time taken for the disappearance of fever, cough, and pulmonary rales versus PIP/TAZ alone (P < .05). These findings suggest that the combination regimen was more effective at resolving the key clinical symptoms of bronchopneumonia in children, which is important for improving patient outcomes and reducing the duration of illness. Patients given PIP/TAZ plus erythromycin experienced lower serum levels of the inflammatory markers CRP, TNF-α, and IL-8 as compared with patients given PIP/TAZ alone (P < .05). The reduction in these inflammatory factors indicates that the addition of erythromycin may have provided greater anti-inflammatory benefits beyond the antimicrobial effects of PIP/TAZ alone. Modulating the inflammatory response is clinically significant, as excessive inflammation can contribute to lung damage and disease severity in pneumonia. Conversely, the observation group showed a higher incidence of gastrointestinal disturbances, including increased stool frequency, watery stools, and elevated stool white blood cell counts after treatment (P < .05), suggesting that the erythromycin component may have disrupted the balance of intestinal flora. Maintaining a healthy gut microbiome is important for overall health, immunity, and preventing further complications. The clinical significance of this finding is that the addition of erythromycin to the treatment regimen may have unintended adverse effects on the gut that should be carefully monitored.ConclusionPIP/TAZ plus erythromycin might be a promising candidate in the treatment of children with bronchopneumonia by significantly improving clinical outcomes, shortening the duration of key symptoms, and regulating the level of inflammatory factors. These findings suggest the combination regimen could provide greater clinical benefits compared to PIP/TAZ alone for managing pediatric bronchopneumonia. However, the addition of erythromycin also appeared to aggravate the imbalance of intestinal flora, as evidenced by the increased incidence of gastrointestinal disturbances. Maintaining a healthy gut microbiome is crucial for overall health and immunity in growing children. Therefore, clinicians must carefully weigh the potential benefits of improved antimicrobial and anti-inflammatory effects against the potential risks of disrupting the delicate gut ecosystem when considering the use of antibiotic combinations for pediatric patients. In conclusion, PIP/TAZ plus erythromycin may be a viable treatment option for children with bronchopneumonia, but clinicians should monitor for any unintended impacts on the gut flora and be prepared to make adjustments to the regimen if necessary. Careful consideration of the balance between therapeutic efficacy and preserving intestinal health is essential when prescribing antibiotic combinations, especially in the pediatric population.

项与地塞米松/哌拉西林/他唑巴坦相关的新闻（医药）

2024-02-02

·药明康德

2月4款创新药有望获FDA批准

根据PDUFA的预期目标日期，预计2月，美国FDA将对4款创新药物的批准做出监管决定，本文将对这些疗法进行相关介绍。活性成分：Taniborbactam 适应症：复杂性尿路感染公司名称：Venatorx Pharmaceuticals Venatorx Pharmaceuticals公司开发的taniborbactam是一种β-内酰胺酶抑制剂（BLI），与第四代头孢菌素头孢吡肟联用，可降低细菌对头孢吡肟的耐药性。头孢吡肟/taniborbactam已被美国FDA授予合格传染病产品（QIDP）和快速通道资格。值得一提的是，中国的云顶新耀公司已与Venatorx达成研发合作，共同开发头孢吡肟/taniborbactam。去年8月，该公司宣布，美国FDA已接受为由头孢吡肟和taniborbactam构成的组合疗法递交的新药申请（NDA），用于治疗复杂性尿路感染（包括急性肾盂肾炎）成人患者。FDA同时授予这一申请优先审评资格，预计在今年2月22日之前给出审评结果。这一NDA得到关键性3期临床试验CERTAIN-1结果的支持。试验结果显示，头孢吡肟/taniborbactam达到了试验的主要终点，与活性对照组相比，达到统计学非劣效性标准。头孢吡肟/taniborbactam组70.0%的患者达到临床和微生物学应答（细菌根除）的复合终点，活性对照组这一数值为58%。在达到非劣效性主要终点后的预定优效性分析显示头孢吡肟/taniborbactam组合表现出统计学优效性。活性成分：Lifileucel 适应症：黑色素瘤公司名称：Iovance Biotherapeutics Lifileucel是基于患者自身的肿瘤浸润淋巴细胞（TIL）构建的细胞疗法，这些TIL在癌症发生时会迁移到肿瘤处并且对肿瘤发起攻击。然而，通常患者体内的TIL数目不足以消灭肿瘤，而且肿瘤微环境会抑制TIL的功能。这款疗法通过从患者体内获取肿瘤组织并且提取TIL，然后在体外使用IL-2细胞因子以刺激TIL的扩增。这一体外刺激手段不但增加了TIL的数量，还能激活TIL的抗肿瘤能力。然后这些TIL被注回患者体内，更有效地杀伤肿瘤细胞。去年5月，Iovance Biotherapeutics公司宣布，FDA已接受lifileucel用于治疗晚期黑色素瘤患者的生物制品许可申请（BLA），并授予其优先审评资格。此次BLA申请得到了C-144-01临床试验积极结果的支持，该试验针对先前在抗PD-1/L1治疗和靶向治疗（如适用）期间或之后出现疾病进展的晚期黑色素瘤患者。试验结果表明，一次性注射lifileucel，能够在接受过PD-1抑制剂和BRAF/MEK靶向疗法的难治性患者中，达到34.3%的总缓解率。如果lifileucel获得加速批准，那么3期临床试验TILVANCE-301可作为支持完全批准的验证性研究。Iovance预计在FDA批准之时，TILVANCE-301试验已经顺利开展。活性成分：Roluperidone 适应症：精神分裂症公司名称：Minerva Neurosciences Roluperidone是一种在研小分子拮抗剂，开发用以治疗精神分裂症的阴性症状。该疗法已被证明可以阻断血清素、sigma和α-肾上腺素能受体，这些受体都参与调节重要的大脑功能，包括情绪、认知、睡眠和焦虑。Roluperidone旨在避免直接阻断多巴胺能受体（第一代和第二代抗精神病药的关键药理学靶点），同时保持对血清素受体的特定亚型5-HT2A（第二代抗精神病药的另一个关键靶点）以及其他药理学靶点（sigma2和肾上腺素-α1A）的阻断。去年5月，Minerva Neurosciences公司宣布美国FDA已接受为roluperidone递交的NDA，用于治疗精神分裂症患者的症状（包括难以享受生活、脱离人群等）。预计在今年2月26日之前做出审评决定。活性成分：Enmetazobactam 适应症：复杂性尿路感染公司名称：Allecra Therapeutics Enmetazobacta是Allecra公司开发的β-内酰胺酶抑制剂。与头孢吡肟联用，旨在对抗革兰氏阴性菌的耐药性，尤其是由β-内酰胺酶介导的超广谱耐药性。Enmetazobacta/头孢吡肟组合已经获得美国FDA授予的合格传染病产品资格（QIDP）。去年6月，Allecra公司宣布已经向美国FDA递交头孢吡肟/enmetazobactam组合的新药申请，用于治疗复杂性尿路感染。此次NDA的提交得到了一项随机双盲、含活性对照的3期试验ALLIUM结果的支持，该试验在复杂性尿路感染患者中研究了头孢吡肟/enmetazobacta与哌拉西林/他唑巴坦（当前标准治疗）相比的疗效。在临床治愈和微生物学根除的主要复合终点方面，与哌拉西林/他唑巴坦相比，头孢吡肟/enmetazobacta达到非劣效性和优效性标准。今年1月，Allecra Therapeutics的合作伙伴Advanz Pharma宣布，欧洲药品管理局（EMA）人用药品委员会（CHMP）已发表了积极意见，推荐批准这款抗生素组合在欧盟上市。参考资料： [1] Venatorx Pharmaceuticals Announces FDA Acceptance and Priority Review of New Drug Application for Cefepime-Taniborbactam to Treat Complicated Urinary Tract Infections (cUTI), including Pyelonephritis, in Adults. Retrieved January 31, 2024, from https://venatorx.com/press-releases/venatorx-pharmaceuticals-announces-fda-acceptance-and-priority-review-of-new-drug-application-for-cefepime-taniborbactam-to-treat-complicated-urinary-tract-infections-cuti-including-pyelonephritis/ [2] Minerva Neurosciences Announces Update on its New Drug Application (NDA) for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia. Retrieved January 31, 2024, from https://ir.minervaneurosciences.com/news-releases/news-release-details/minerva-neurosciences-announces-update-its-new-drug-0 内容来源于网络，如有侵权，请联系删除。

优先审批快速通道临床结果合格传染病产品

2010-05-05

·Pharma Times

Pfizer turnover leaps thanks to Wyeth drugs

Pfizer has reported a major rise in sales for the first quarter, thanks to the contribution of Wyeth, but like at Merck & Co, charges from that acquisition pushed the drug giant’s earnings down. Net profit fell 26% to $2.03 billion, while turnover came in at $16.75 billion, an increase of 54%, and 48% of that rise was due to Wyeth products. Sales of Pfizer’s own drugs actually slipped 1%. Biopharmaceutical sales leapt 44% to $14.51 billion and revenues from the cholesterol blockbuster Lipitor (atorvastatin) edged up 1% to $2.76 billion, though US sales fell 10% to $1.31 billion, hit by competition from other statins, notably the generic version of Merck & Co’s Zocor (simvastatin). Generic competition also hurt the blood pressure treatment Norvasc (amlodipine), which fell 23% to $368 million. On the positive side, sales of Lyrica (pregabalin), for epilepsy, fibromyalgia and neuropathic pain, increased 6% to $723 million, while the kidney cancer treatment Sutent (sunitinib) jumped 28%% to $259 million. The COX-2 inhibitor Celebrex (celecoxib) inched up 1% to $570 million and the erectile dysfunction drug Viagra (sildenafil) brought in $479 million, up 5%, while the glaucoma drug Xalatan (latanoprost) had sales of $422 million (+4%). The smoking cessation drug Chantix/Champix (varenicline) rose 7% to $189 million. The figures were boosted by a number of Wyeth products, notably the antidepressant Effexor (venlafaxine), which contributed $716 million, the pneumococcal disease vaccine Prevnar ($286 million) and the arthritis and psoriasis therapy Enbrel (etanercept; $802 million outside North America). Wyeth’s antibiotic Zosyn/Tazocin (piperacillin/tazobactam) brought in $264 million, while the Premarin (conjugated oestrogens) range of hormone replacement therapies contributed $256 million to Pfizer’s coffers. Pfizer’s new ‘diversified’ division, which includes animal and consumer health products, plus nutritional items and capsules for drugs made by Wyeth, saw revenues climb 210% to $2.14 billion. US healthcare reforms reduced first-quarter revenues by $56 million. The latter effect will impact sales by about $300 million this year, said chief financial officer Frank D’Amelio, but he noted that the company is sticking by its earnings forecast of $2.10-$2.20 per share, with revenues expected to be $67-$69 billion. However, for 2012, Pfizer is targeting turnover of $65.2-$67.7 billion, down $800 million on a previous guidance.

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100 项与地塞米松/哌拉西林/他唑巴坦相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
中耳炎	临床2期	-	Yuhan Corp.	-

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ERS2019	N/A	肺炎	43	Cefepime with Ciprofloxacin	糧衊製糧膚醖鏇選鑰糧(築壓艱鹹選鬱鹹獵範壓) = 顧獵積襯獵獵製構齋願簾壓蓋獵簾網範衊遞觸 (鏇遞窪醖鬱襯簾膚構醖 ) 更多	-	2019-09-28
				Piperacillin/tazobactam with Ciprofloxacin	糧衊製糧膚醖鏇選鑰糧(築壓艱鹹選鬱鹹獵範壓) = 膚壓襯蓋壓獵壓夢願襯簾壓蓋獵簾網範衊遞觸 (鏇遞窪醖鬱襯簾膚構醖 ) 更多
ASN2018	N/A	-	6	Meropenem	艱鏇夢鏇鹹憲顧積鹽遞(觸廠憲範顧網顧壓鹽淵) = 範膚遞鹽壓壓網遞廠構廠網顧範網夢艱衊膚艱 (夢夢鬱鏇窪鹹壓窪繭齋 ) 更多	-	2018-10-23
				Piperacillin/Tazobactam	艱鏇夢鏇鹹憲顧積鹽遞(觸廠憲範顧網顧壓鹽淵) = 顧範淵範網夢網鹹衊憲廠網顧範網夢艱衊膚艱 (夢夢鬱鏇窪鹹壓窪繭齋 ) 更多
ASN2016	N/A	急性肾损伤	5,370	Vancomycin/Cefepime	築顧製壓鹹膚齋製夢繭(窪夢鏇顧網艱構築齋簾) = 鹽獵鹹鬱鹽顧積積網夢觸鬱糧糧鬱壓願構顧積 (選蓋壓餘鹽獵壓獵鹹艱 )	不佳	2016-11-15
				Vancomycin/Piperacillin-Tazobactam	築顧製壓鹹膚齋製夢繭(窪夢鏇顧網艱構築齋簾) = 齋壓廠簾鑰鑰鬱夢製觸觸鬱糧糧鬱壓願構顧積 (選蓋壓餘鹽獵壓獵鹹艱 )