MALVERN, Pa. & PARSIPPANY, N.J.--(BUSINESS WIRE)--Venatorx Pharmaceuticals (Venatorx) and Melinta Therapeutics (Melinta) announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for cefepime-taniborbactam, a beta-lactam/beta-lactamase inhibitor (BL/BLI) combination antibiotic under review as a potential treatment for adult patients with complicated urinary tract infections (cUTI), including acute pyelonephritis caused by susceptible gram-negative microorganisms..

宾夕法尼亚州马尔文（MALVERN）和新泽西州帕西帕尼（PARSIPPANY）--（商业新闻短讯）--Venatorx Pharmaceuticals（Venatorx）和Melinta Therapeutics（Melinta）今天宣布，美国食品和药物管理局（FDA）发布了一份关于头孢吡肟/β-内酰胺酶抑制剂（BL/BLI）的新药申请（NDA）的完整回复信（CRL）正在审查的联合抗生素作为成人复杂尿路感染（cUTI）患者的潜在治疗方法，包括由易感革兰氏阴性微生物引起的急性肾盂肾炎。。

The CRL did not identify clinical safety or efficacy issues in the NDA, and the FDA did not request any new clinical trials to support the approval of cefepime-taniborbactam. The FDA requested additional chemistry, manufacturing, and controls (CMC) and related data about the drug, testing methods, and manufacturing process..

CRL没有在NDA中确定临床安全性或有效性问题，FDA也没有要求任何新的临床试验来支持头孢吡肟他尼巴坦的批准。FDA要求提供额外的化学、制造和控制（CMC）以及有关药物、测试方法和制造过程的相关数据。。

“While we are disappointed with this setback, we maintain utmost confidence in cefepime-taniborbactam. We are already hard at work generating the additional requested CMC data, and we will continue to work closely with the FDA so that we can make this important new medicine available to patients as quickly as possible,” said Christopher J.

“虽然我们对这一挫折感到失望，但我们对头孢吡肟他尼巴坦保持最大的信心。我们已经在努力生成额外要求的CMC数据，我们将继续与FDA密切合作，以便我们能够尽快将这种重要的新药提供给患者，”克里斯托弗J。

Burns, Ph.D., Chief Executive Officer of Venatorx..

Burns博士，Venatorx首席执行官。。

Melinta Chief Executive Officer and President, Christine Ann Miller added, “We are committed to our plans of supporting the US commercialization of this drug, which we believe when approved, will offer healthcare providers an important therapy for adult patients suffering from complicated urinary tract infections including acute pyelonephritis caused by susceptible gram-negative microorganisms.”.

Melinta首席执行官兼总裁Christine Ann Miller补充道：“我们致力于支持这种药物在美国商业化的计划，我们相信一旦批准，将为医疗保健提供者提供一种重要的治疗方法，用于治疗患有复杂尿路感染的成年患者，包括易感革兰氏阴性微生物引起的急性肾盂肾炎。”。

About Cefepime-Taniborbactam

关于头孢吡肟替尼巴坦

Cefepime-taniborbactam is an investigational intravenous (IV) beta-lactam/beta-lactamase inhibitor (BL/BLI) antibiotic combination being developed for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis, and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in adults..

头孢吡肟他尼巴坦是一种研究性静脉注射（IV）β-内酰胺/β-内酰胺酶抑制剂（BL/BLI）抗生素组合，用于治疗复杂的尿路感染（皮肤），包括肾盂肾炎，以及成人医院获得性细菌性肺炎和呼吸机相关细菌性肺炎（HABP/VABP）。。

Cefepime, a fourth-generation cephalosporin, is a widely used beta-lactam (BL) antibiotic with more than two decades of proven safety and clinical utility against susceptible gram-negative and gram-positive bacteria. Taniborbactam is a beta-lactamase inhibitor (BLI) that, in combination with cefepime, is being studied as a potential treatment option for patients with serious bacterial infections caused by antibiotic resistant gram-negative bacteria, most notably Extended Spectrum Beta-lactamase (ESBL)-expressing Enterobacterales, carbapenem-resistant Enterobacterales (CRE), and multidrug-resistant (MDR) Pseudomonas aeruginosa (MDR-PA), which can include carbapenem-resistant P.

头孢吡肟是第四代头孢菌素，是一种广泛使用的β-内酰胺（BL）抗生素，对易感的革兰氏阴性菌和革兰氏阳性菌具有20多年的安全性和临床实用性。他尼巴坦是一种β-内酰胺酶抑制剂（BLI），与头孢吡肟联合使用，正在研究作为由抗生素耐药革兰氏阴性菌引起的严重细菌感染患者的潜在治疗选择，最显着的是表达超广谱β-内酰胺酶（ESBL）的肠杆菌，耐碳青霉烯的肠杆菌（CRE）和耐多药（MDR）铜绿假单胞菌（MDR-PA），其中可能包括耐碳青霉烯的P。

aeruginosa (CRPA)..

铜绿假单胞菌（CRPA）。。

Cefepime-taniborbactam has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the U.S. Food and Drug Administration (FDA). Fast Track designation is designed to facilitate the development, and to expedite the review of drugs to treat serious conditions that do not have sufficient treatment options.

头孢吡肟他尼巴坦已被美国食品和药物管理局（FDA）授予合格的传染病产品（QIDP）和快速通道名称。快速通道指定旨在促进开发，并加快对药物的审查，以治疗没有足够治疗选择的严重疾病。

QIDP designation provides certain incentives for the development of new antibiotics, including priority review, as well as a five-year regulatory exclusivity extension. QIDP was authorized under the Generating Antibiotic Incentives Now (GAIN) Act of 2012, as part of the FDA Safety and Innovation Act, to underscore the urgency in development of new antibiotics..

QIDP指定为开发新抗生素提供了一定的激励措施，包括优先审查，以及五年的监管排他性延长。QIDP是根据2012年《立即产生抗生素激励（GAIN）法案》授权的，作为FDA安全与创新法案的一部分，以强调开发新抗生素的紧迫性。。

About Gram-Negative Infections and Antimicrobial Resistance (AMR)

关于革兰氏阴性感染和抗菌药物耐药性（AMR）

In a recent report on AMR, the U.S. Centers for Disease Control and Prevention (CDC) reported rates of resistance have increased significantly in the U.S. among bacterial pathogens including those commonly causing cUTI, pyelonephritis, and bacteremia. The CDC also cited that there are more than 2.8 million AMR infections annually in the U.S., which are directly related to more than 35,000 deaths.[1].

在最近一份关于AMR的报告中，美国疾病控制和预防中心（CDC）报告说，美国细菌病原体的耐药率显着增加，包括通常引起角质层，肾盂肾炎和菌血症的病原体。疾病预防控制中心还指出，美国每年有280多万AMR感染者，这与35000多人死亡直接相关。[1] 。

Between 2014 and 2019, an analysis of U.S. UTI patients determined that 4.4% of cases were carbapenem resistant (CR) and 24.5% of U.S. UTI patients were bacteremic with 1.7% of cases caused by a CR pathogen. Patients with CR infections had a significantly longer hospital length of stay (LOS), were less likely to be discharged home, had a higher readmission rate, and had greater LOS-associated charges than patients with carbapenem-susceptible infections.

在2014年至2019年期间，对美国UTI患者的分析确定，4.4%的病例是碳青霉烯类耐药（CR），24.5%的美国UTI患者是菌血症，1.7%的病例是由CR病原体引起的。与碳青霉烯类易感感染患者相比，CR感染患者的住院时间（LOS）明显更长，出院回家的可能性更小，再入院率更高，LOS相关费用更高。

Additionally, patients with bacteremia (urosepsis) due to CR pathogens had a significantly higher rate of mortality than those with carbapenem susceptible pathogens.[2].

此外，由CR病原体引起的菌血症（尿脓毒症）患者的死亡率明显高于碳青霉烯类易感病原体患者。[2] 。

Gram-negative bacteria have multiple AMR mechanisms that continue to adapt in response to increases in antibiotic usage. Carbapenems are broad-spectrum antibiotics that have been widely used to treat infections caused by multidrug-resistant gram-negative bacteria, including Enterobacterales. With the increased global use of carbapenems, CRE have emerged, which have limited treatment options and are associated with increased morbidity and mortality.

革兰氏阴性菌具有多种AMR机制，可继续适应抗生素使用量的增加。碳青霉烯类是广谱抗生素，已被广泛用于治疗由多重耐药革兰氏阴性菌（包括肠杆菌）引起的感染。随着碳青霉烯类药物的全球使用增加，CRE已经出现，其治疗选择有限，并且与发病率和死亡率增加有关。

Resistance to carbapenems among Enterobacterales is primarily achieved by production of carbapenemases, which are enzymes capable of hydrolyzing carbapenem antibiotics and most other beta-lactams and fall into two distinct families: serine beta-lactamases and metallo-beta-lactamases (MBLs). Klebsiella pneumoniae carbapenemase (KPC), a class-A serine beta-lactamase, is one of the most prevalent carbapenemases, and New Delhi MBL (NDM) and Verona Integron-encoded MBL (VIM) are common variants of MBLs identified in gram-negative infections due to Enterobacterales and P.

肠杆菌对碳青霉烯类的耐药性主要是通过产生碳青霉烯酶来实现的，碳青霉烯酶是能够水解碳青霉烯类抗生素和大多数其他β-内酰胺的酶，分为两个不同的家族：丝氨酸β-内酰胺酶和金属β-内酰胺酶（MBL）。肺炎克雷伯菌碳青霉烯酶（KPC）是一种a类丝氨酸β-内酰胺酶，是最普遍的碳青霉烯酶之一，新德里MBL（NDM）和维罗纳整合子编码的MBL（VIM）是由肠杆菌和P引起的革兰氏阴性感染中鉴定出的MBL的常见变体。

aeruginosa. According to an IHMA surveillance study in 2018-2019 and a JMI U.S. Surveillance study from 2021, MBLs were the most commonly identified carbapenem resistance mechanism globally among Enterobacterales isolates, with ~16 to 18% of U.S. CRE isolates carrying MBLs.[3,4].

铜绿假单胞菌。根据2018-2019年IHMA监测研究和2021年JMI美国监测研究，MBLs是全球肠杆菌分离株中最常见的碳青霉烯类耐药机制，约有16%至18%的美国CRE分离株携带MBLs。

While CRPA is also increasing in some geographies due to emergence of MBLs, MDR-PA, which may exhibit resistance to carbapenems, represents an increasing challenge for clinicians and their patients in the U.S. and globally due to the paucity of treatment options for this primarily hospital-associated pathogen.

虽然由于MBL的出现，CRPA在某些地区也在增加，但可能对碳青霉烯类药物产生耐药性的MDR-PA对美国和全球的临床医生及其患者来说是一个越来越大的挑战，因为这种主要与医院相关的病原体缺乏治疗选择。

Especially outside the U.S., CRPA may carry carbapenemases including MBLs (i.e., VIM); however, non-carbapenemase resistance mechanisms (i.e., efflux pumps, porins) also contribute to the growing global resistance of MDR-PA and CRPA.[5].

特别是在美国以外，CRPA可能携带碳青霉烯酶，包括MBL（即VIM）；然而，非碳青霉烯酶耐药机制（即外排泵，孔蛋白）也导致MDR-PA和CRPA的全球耐药性增加。[5] 。

If AMR infections continue on this trajectory, it has been projected that an estimated 10 million people will die per year of resistant infections by 2050—a number that surpasses the projected annual number of deaths (8.2 million) caused by cancer—and the cumulative cost to the global economy could be as high as U.S.

如果AMR感染继续沿着这一轨迹发展，预计到2050年，每年将有1000万人死于耐药性感染，这一数字超过了预计的每年癌症死亡人数（820万），全球经济的累积成本可能高达美国。

$100 trillion.[6] In the U.S., estimates have reached as high as U.S. $20 billion in excess direct healthcare costs, with an additional U.S. $35 billion associated with lost productivity.[7] By 2050, the world is at risk of losing up to 3.8% of its annual gross domestic product with an annual shortfall of up to U.S.

100万亿美元。[6] 在美国，估计超额直接医疗费用高达200亿美元，另外还有350亿美元与生产力损失有关。[7] 到2050年，世界面临着每年国内生产总值（GDP）损失高达3.8%的风险，年缺口高达美国。

$3.4 trillion by 2030, a figure on par with losses attributable to the 2008 global financial crisis.[8].

到2030年将达到3.4万亿美元，相当于2008年全球金融危机造成的损失。[8] 。

The Infectious Disease Society of America (IDSA) maintains updated guidance on the Treatment of Antimicrobial Resistant Gram-Negative Infections online at https://www.idsociety.org/practice-guideline/amr-guidance/.[9] For those patients who do not respond to current treatment, new antibiotic therapies are needed to combat AMR..

美国传染病学会（IDSA）在线维护关于抗药性革兰氏阴性菌感染治疗的最新指南https://www.idsociety.org/practice-guideline/amr-guidance/.[9] 对于那些对目前的治疗没有反应的患者，需要新的抗生素疗法来对抗AMR。。

About Complicated Urinary Tract Infections

关于复杂性尿路感染

Complicated UTIs, which include pyelonephritis, are defined as urinary tract infections ascending from the bladder accompanied by local and systemic signs and symptoms, including fever, chills, malaise, flank pain, back pain, and/or costovertebral angle pain or tenderness, that usually occur in the presence of a functional or anatomical abnormality of the urinary tract or in the presence of catheterization.

复杂的尿路感染，包括肾盂肾炎，被定义为从膀胱上升的尿路感染，伴有局部和全身体征和症状，包括发烧、寒战、不适、腰痛、背痛和/或肋椎角疼痛或压痛，通常发生在泌尿道功能或解剖异常或导尿的情况下。

Bacteremia can arise secondary to infections like cUTI and can result in substantial morbidity and mortality. [1] Annually in U.S., it is estimated that more than 3 million cUTI patients will be diagnosed and require antibiotic therapy leading to over $6 billion in annualized 30-day costs.[10].

菌血症可能继发于像cUTI这样的感染，并可能导致严重的发病率和死亡率。[1] 在美国，每年估计将有300多万cUTI患者被诊断出并需要抗生素治疗，导致每年30天的费用超过60亿美元。[10] 。

About Venatorx Pharmaceuticals

关于Venatorx Pharmaceuticals

Venatorx is a private, late-stage clinical pharmaceutical company focused on improving health outcomes for patients with multidrug-resistant bacterial infections and hard-to-treat viral infections. Venatorx’s lead program, cefepime-taniborbactam, is a clinical-stage antibiotic that completed a Phase 3 study in adults with complicated urinary tract infections (cUTI), including pyelonephritis.

Venatorx是一家私营的晚期临床制药公司，专注于改善耐多药细菌感染和难以治疗的病毒感染患者的健康状况。Venatorx的领导项目头孢吡肟-他尼巴坦是一种临床阶段抗生素，完成了包括肾盂肾炎在内的复杂尿路感染（cUTI）成人的3期研究。

In October 2022, BARDA awarded a contract of up to $318M for development and procurement of cefepime-taniborbactam for the treatment of melioidosis and multi-drug resistant infections. Cefepime-taniborbactam is currently under review by the FDA for the treatment of cUTI, including acute pyelonephritis.

2022年10月，BARDA授予了一份高达3.18亿美元的合同，用于开发和采购头孢吡肟-他尼巴坦，用于治疗类鼻疽和耐多药感染。头孢吡肟他尼巴坦目前正在FDA审查用于治疗包括急性肾盂肾炎在内的cUTI。

Venatorx is also developing an oral antibacterial, ceftibuten-ledaborbactam (formerly known as VNRX-7145), for the treatment of cUTI, including pyelonephritis, caused by certain bacteria in adult patients with limited treatment options; this product is completing Phase 1 and will advance directly to a global Phase 3 cUTI clinical trial.

Venatorx还开发了一种口服抗菌药物头孢布烯-利巴巴坦（以前称为VNRX-7145），用于治疗由治疗选择有限的成年患者中某些细菌引起的cUTI，包括肾盂肾炎；该产品正在完成第一阶段，将直接进入全球第三阶段cUTI临床试验。

For more information about Venatorx and its anti-infectives portfolio, please visit www.venatorx.com..

有关Venatorx及其抗感染药物组合的更多信息，请访问www.Venatorx.com。。

About Melinta Therapeutics LLC

关于Melinta Therapeutics LLC

Melinta Therapeutics is a biopharmaceutical company dedicated to providing innovative therapies to people impacted by acute and life-threatening illnesses. We focus our expanding portfolio on serving patients with an unmet need because that’s how we make the most meaningful impact. At Melinta, we’re visionaries dedicated to innovation while staying grounded in what matters most: patients.

Melinta Therapeutics是一家生物制药公司，致力于为受急性和危及生命的疾病影响的人提供创新疗法。我们将不断扩大的投资组合重点放在为未满足需求的患者提供服务上，因为这就是我们如何产生最有意义的影响。在梅林塔，我们是致力于创新的远见者，同时立足于最重要的事情：患者。

Our portfolio currently includes seven commercial-stage products: BAXDELA® (delafloxacin), KIMYRSA® (oritavancin), MINOCIN® (minocycline) for Injection, ORBACTIV® (oritavancin), REZZAYO® (rezafungin for injection), TOPROL-XL® (metoprolol succinate) and VABOMERE® (meropenem and vaborbactam). For more information about Melinta Therapeutics, our commitment to patients, and to learn about our portfolio of therapies, visit www.melinta.com..

我们的产品组合目前包括七种商业舞台产品：BAXDELA®（delafloxacin），KIMYRSA®（oritavancin），注射用米诺环素®（minocycline），ORBACTIV®（oritavancin），REZZAYO®（注射用瑞扎芬净），TOPROL-XL®（琥珀酸美托洛尔）和VABOMERE®（美罗培南和瓦博巴坦）。有关Melinta Therapeutics、我们对患者的承诺以及我们的治疗组合的更多信息，请访问www.Melinta.com。。

Funding Partners and Collaborators for Cefepime-Taniborbactam

头孢吡肟他尼巴坦的资助伙伴和合作者

This project has been funded in part with federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under contract number HHSN272201300019C, and Wellcome Trust under Award No. 360G-Wellcome-101999/Z/13/Z, and has continued with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority, under contract numbers HHSO100201900007C and 75A50122C00080..

该项目部分由美国国家过敏与传染病研究所、美国国立卫生研究院、卫生与公众服务部的联邦资金资助，合同号为HHSN272201300019C，惠康信托基金的合同号为360G-Wellcome-101999/Z/13/Z，并继续由卫生与公众服务部的联邦资金资助；生物医学高级研究与发展局战略准备与响应管理局，合同号HHSO100201900007C和75A50122C00080。。

In September 2018, Venatorx entered into an exclusive license agreement with Everest Medicines to support the development, registration, and commercialization of cefepime-taniborbactam in Greater China, South Korea, and select countries in Southeast Asia. Everest will be solely responsible for the commercialization of cefepime-taniborbactam in its territory and Venatorx will be eligible to receive royalties on net sales..

2018年9月，Venatorx与Everest Medicines签订了独家许可协议，以支持头孢吡肟-他尼巴坦在大中华区，韩国和东南亚部分国家的开发，注册和商业化。珠穆朗玛峰将全权负责头孢吡肟替尼巴坦在其境内的商业化，Venatorx将有资格获得净销售额的版税。。

In April 2020, Venatorx and the GARDP Foundation (GARDP) announced a collaboration to accelerate the development of, and access to, cefepime-taniborbactam for adult and pediatric populations. Venatorx has granted GARDP exclusive rights to distribute and sub-distribute cefepime-taniborbactam, once it is approved for clinical use, in low- and lower-middle-income countries..

2020年4月，Venatorx和GARDP基金会（GARDP）宣布合作，以加速成人和儿科人群头孢吡肟-他尼巴坦的开发和使用。Venatorx已授予GARDP独家经销权，一旦头孢吡肟-他尼巴坦被批准用于临床，即可在中低收入国家分销和再分销。。

In November 2023, Venatorx and Melinta entered into an exclusive License Agreement to facilitate a strategic partnership in the U.S. to commercialize cefepime-taniborbactam, a beta-lactam / beta-lactamase inhibitor (BL/BLI) combination antibiotic being developed for the treatment of complicated urinary tract infections (cUTI) and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in adults..

2023年11月，Venatorx和Melinta签订了独家许可协议，以促进美国的战略合作伙伴关系，将头孢吡肟-他尼巴坦商业化，头孢吡肟-他尼巴坦是一种β-内酰胺/β-内酰胺酶抑制剂（BL/BLI）组合抗生素，正在开发用于治疗复杂尿路感染（cUTI）成人医院获得性细菌性肺炎和呼吸机相关性细菌性肺炎（HABP/VABP）。。

In December 2023, Venatorx entered into an agreement with Menarini Group, who acquired the exclusive rights to commercialize, upon approval of relevant health authorities, cefepime-taniborbactam in 96 countries in Europe, Latin America, Middle East, Turkey and North Africa and the Commonwealth of Independent States (CIS)..

2023年12月，Venatorx与美纳里尼集团（Menarini Group）签订了一项协议，经相关卫生部门批准，美纳里尼集团获得了头孢吡肟他尼巴坦在欧洲、拉丁美洲、中东、土耳其和北非96个国家以及独联体（CIS）商业化的专有权。。

References

参考文献

[1] Antibiotic Resistance Threats in the United States 2019, U.S. Department of Health and Human Services, Centers for Disease Control and Prevention.

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