This study is non-inferiority trial design. This study aimed to investigate the effect of prophylactic oral antibiotics on preventing cholangitis in biliary atresia (BA) patients after Kasai portoenterostomy (KP) by comparing the cholangitis rate in BA patients who received prophylactic oral antibiotics and those who did not. The patients were followed up for 2 years after KP.

Start Date01 Jul 2023

Sponsor / Collaborator

Paediatrics Hospital Affiliated To Fudan University

CTR20221980 / CompletedPhase 1

注射用头孢哌酮钠舒巴坦钠（3:1）在中国健康人体中的药代动力学研究

[Translation] Study on the pharmacokinetics of cefoperazone sodium and sulbactam sodium for injection (3:1) in healthy Chinese volunteers

主要目的： 1）研究健康成年受试者单次静脉滴注低、中、高剂量的试验药物或单一剂量的对照药物，头孢哌酮和舒巴坦的药代动力学特征。 2）研究健康成年受试者多次静脉滴注试验药物或对照药物后，头孢哌酮和舒巴坦的药代动力学特征。次要目的 1）评价健康成年受试者单次静脉滴注低、中、高剂量的试验药物或单一剂量的对照药物后的安全性。 2）评价健康成年受试者多次静脉滴注试验药物或对照药物后的安全性。

[Translation]

Main objectives: 1) To study the pharmacokinetic characteristics of cefoperazone and sulbactam after single intravenous infusion of low, medium and high doses of test drugs or single doses of control drugs in healthy adult subjects. 2) To study the pharmacokinetic characteristics of cefoperazone and sulbactam after multiple intravenous infusions of test drugs or control drugs in healthy adult subjects. Secondary objectives 1) To evaluate the safety of healthy adult subjects after single intravenous infusion of low, medium and high doses of test drugs or single doses of control drugs. 2) To evaluate the safety of healthy adult subjects after multiple intravenous infusions of test drugs or control drugs.

Start Date08 Sep 2022

Sponsor / Collaborator

Xiangbei Welman Pharmaceutical Co., Ltd.

NCT05535309 / CompletedNot ApplicableIIT

Epidemiological Study on Drug-induced Coagulation Disorder Caused by Cefoperazone Sulbactam Sodium and Construction of Prediction Model

The incidence rate of drug-induced blood diseases accounts for about 10% of all drug-induced diseases, most of which are serious at the time of onset, and the mortality rate can be as high as 32.5%. In this study, cefoperazone sulbactam sodium, which is commonly used in clinic, was selected as the target drug, and the epidemiological characteristics of drug-induced coagulation dysfunction and the construction of risk factor models were studied by single factor and multiple factor Logistic regression analysis.

Start Date02 Nov 2021

Sponsor / Collaborator

Qianfoshan Hospital of Shandong Province

100 Clinical Results associated with Cefoperazone Sodium/Sulbactam Sodium

100 Translational Medicine associated with Cefoperazone Sodium/Sulbactam Sodium

100 Patents (Medical) associated with Cefoperazone Sodium/Sulbactam Sodium

Literatures (Medical) associated with Cefoperazone Sodium/Sulbactam Sodium

06 Oct 2024·Zhonghua yu fang yi xue za zhi [Chinese journal of preventive medicine]

[Analysis of the changes of bacterial spectrum and drug resistance in sputum culture of ICU children in a hospital of pediatric in Jiangsu Province from 2017 to 2022].

Article

Author: Huang, H ; Tan, Q X ; Wei, J ; Xue, J ; Shen, H J ; Wang, C

Objective: To investigate the changes of the distribution and drug resistance profile of bacteria from ICU children with lower respiratory tract infection (LRTI) in Suzhou City, Jiangsu Province from 2017 to 2022. Methods: From January 2017 to December 2022, a cross-sectional observational study on the bacterial spectrum analysis among intensive care unit (ICU) children with LRTI was conducted in Children's Hospital of Soochow University. The bacteria was cultivated by culture methods from sputum samples, and identified by MALDI-TOF mass spectrometry. Drug sensitivity tests were performed by the VITEK2 Compact fully automated analysis system and the paper slide method. The χ² test or Fisher's exact probability was used to analyze the changes of the distribution of sputum culture-positive bacteria and drug resistance in ICU children. Results: The overall detection rate of sputum culture was 42.06% (1 182/2 810). Staphylococcus aureus (25.63%,303/1 182), Acinetobacter baumannii (13.62%,161/1 182) and Haemaphilus influenzae (13.28%,157/1 182) were the top three. Proportions of Acinetobacter baumannii (17.90% vs. 11.02%,χ²=11.17, P=0.001), especially carbapenem-resistant Acinetobacter baumannii (43.70% vs. 23.50%, χ²=15.21, P<0.001) increased significantly from 2020 to 2022. However, the proportions of Haemophilus influenzae (8.50% vs. 16.19%, χ²=14.27, P<0.001), Streptococcus pneumoniae (8.50% vs. 15.92%, χ²=13.42, P<0.001) and extended-spectrum-lactamase producing Escherichia coli (8.89% vs. 18.00%, χ²=5.45, P=0.025) decreased. Drug resistant results showed that Acinetobacter baumannii was obviously more resistant to imipenem (χ²=4.43, P=0.035) and levofloxacin (χ²=12.53, P<0.001), while more sensitive to minocycline (χ²=8.34, P=0.004). Escherichia coli showed a significant increase in resistance to piperacillin tazobactam (χ²=8.29, P=0.008) and cefoperazone sulbactam (χ²=5.07, P=0.024) from 2020 to 2022; Klebsiella pneumoniae consistently maintained a resistance rate of more than 60% to first and second-generation cephalosporins, and remain susceptible to quinolones and carbapenems. Staphylococcus aureus remained highly susceptible to levofloxacin (drug resistance rate: 2.31%,7/303) and sulfamethoxazole/trimethoprim (drug resistance rate: 4.95%,15/303) from 2020 to 2022. Conclusion: Higher detection and resistance rates of Acinetobacter baumannii from sputum culture in ICU children from 2020 to 2022 were explored. Resistance of Escherichia coli to β-lactamase inhibitor combinations was more serious. Regular monitoring the changes of the etiology of respiratory tract infections in ICU Children is particularly important for the prevention and treatment of multidrug-resistant bacterial infections.

01 Mar 2024·Journal of global antimicrobial resistance

In vitro antimicrobial susceptibility data of global meropenem-resistant Acinetobacter baumannii isolates causing pneumonia: Data from the Antimicrobial Testing Leadership and Surveillance Program, 2014–2021, and re-estimations of susceptibility breakpoints and appropriate dosages of important antibiotics for pneumonia treatment

Article

Author: Hsueh, Shun-Chung ; Liu, I-Min ; Huang, Yu-Tsung ; Ko, Wen-Chien ; Jean, Shio-Shin ; Hsieh, Po-Chuen

OBJECTIVES:

To evaluate the susceptibility of globally pneumonia-causing meropenem-resistant (MEM-R) Acinetobacter baumannii isolates against important antibiotics and estimate appropriate dosages of indicated antibiotics.

METHODS:

We extracted the 2014-2021 Antimicrobial Testing of Leadership Surveillance database regarding the susceptibility of MEM-R A. baumannii isolates causing pneumonia against important antibiotics. The susceptibility and carbapenemase-encoding gene (CPEG) data of pneumonia-causing MEM-R A. baumannii isolates from patients hospitalized in intensive care units of five major regions were analyzed. The susceptibility breakpoints (SBP) recommended by the Clinical and Laboratory Standards Institute (CLSI) in 2022, other necessary criteria [SBP of MIC for colistin, 2 mg/L, in the CLSI 2018; and cefoperazone-sulbactam (CFP-SUL), 16 mg/L], and the pharmacokinetic and pharmacodynamic data of indicated antibiotics were employed.

RESULTS:

Applying the aforementioned criteria, we observed the susceptible rates of colistin, minocycline, and CFP-SUL against the pneumonia-causing MEM-R A. baumannii isolates globally (n = 2905) were 93.2%, 69.1%, and 26.3%, respectively. Minocycline was significantly more active in vitro (MIC ≤4 mg/L) against the pneumonia-causing MEM-R A. baumannii isolates collected from North and South America compared to those from other regions (>90% vs. 58-72%). Additionally, bla_OXA-23 and bla_OXA-72 were the predominant CPEG in pneumonia-causing MEM-R A. baumannii isolates.

CONCLUSIONS:

After deliberative estimations, dosages of 200 mg minocycline intravenously every 12 h (SBP, 8 mg/L), 100 mg tigecycline intravenously every 12 h (SBP, 1 mg/L), and 160 mg nebulized colistin methanesulphonate every 8 h (SBP, 2 mg/L) are needed for the effective treatment of pneumonia-causing MEM-R A. baumannii isolates.

01 Feb 2024·Zhejiang da xue xue bao. Yi xue ban = Journal of Zhejiang University. Medical sciences

Article

Author: Pan, Xinling ; Ye, Tinghua ; Shi, Yunzhen ; Wu, Lihua ; Hong, Li

A 82-year-old man was admitted to hospital with fever, unresponsiveness, elevated hypersensitive C-reactive protein and neutrophile granulocyte. Ceftriaxone was administrated by intravenous dripping in the emergency room, but the effect was not satisfactory. Following his admission to the ward, cefoperazone sulbactam were given. Elizabethkingia meningoseptica was identified by blood culture and further confirmed by 16S rRNA sequencing. The lumbar puncture showed that cerebrospinal fluid pressure was 80 mmH₂O (1 mmH₂O=0.0098 kPa) and biochemical results were normal. After 11 days of cefoperazone sulbactam treatment, the patient was discharged with negative blood culture. The hypersensitive C-reactive protein and neutrophile granulocyte had also declined. The patient received levofloxacin tablets for anti-infection treatment for 14 d after discharge. No signs of infection were observed in three months' following up.

News (Medical) associated with Cefoperazone Sodium/Sulbactam Sodium

31 Oct 2023

·firstwordpharma.com

Pfizer swings to loss in Q3 as demand for COVID products dries up

Headline results for the third quarter: Revenue: $13.2 billion (forecasts of $13.8 billion), down 42% Loss: $2.4 billion, versus a profit of $8.6 billion Note: All changes are versus the prior-year period unless otherwise stated What the company said: David Denton, chief financial officer at Pfizer, stated "we are extremely pleased by the strong 10% operational revenue growth of [our] non-COVID products in the third quarter." He added that "withexpected contributions from our new product launches, this puts us squarely on track to meet our full-year non-COVID operational revenue growth target of 6% to 8%."Last month, in announcing the launch of a cost-cutting programme aimed at generating savings of at least $3.5 billion by the end of 2024, the company noted that it would record billions in COVID inventory write-offs. It also revised terms of its US supply agreement for Paxlovid, under which the government would return close to 8 million courses of the COVID antiviral treatment at the end of 2023 in return for a credit for future courses of the drug.On Tuesday, Pfizer said it booked a $5.6-billion charge in the third quarter due to lower-than-expected use of COVID products. Of these write-offs, $4.7 billion was chalked up to Paxlovid, with $900 million attributed to the company's COVID booster, close to what Pfizer had estimated a few weeks ago.Meanwhile, CEO Albert Bourla stated that Pfizer also continues "to make progress" toward its pending $43-billion acquisition of antibody-drug conjugate (ADC) developer Seagen. It is awaiting US antitrust approval for the deal, having recently secured an unconditional nod from regulators in the EU. The companies have said the acquisition is expected to close in late 2023 or early 2024.Other results: Primary care sales: $6.3 billion, down 60% Eliquis alliance revenue and direct sales: $1.5 billion, up 2% Comirnaty: $1.3 billion, down 70%, roughly $200 million short of analyst expectations Prevnar/Prevenar 13 & 20: $1.9 billion, up 15% Abrysvo: $375 million, following FDA approval and subsequent US launch of the respiratory syncytial virus (RSV) vaccine in older adults in May Nurtec ODT/Vydura: $233 million Paxlovid: $202 million, down 97%, missing projections by nearly $170 million Specialty care sales: $3.8 billion, up 10% Vyndaqel/Vyndamax: $892 million, up 48% Xeljanz: $503 million, flat versus the year-ago period Enbrel (outside the US and Canada): $208 million, down 10% Sulperazon: $122 million, down 32% Oxbryta: $85 million Oncology product sales: $2.9 billion, down 6% Ibrance: $1.2 billion, down 3% Xtandi alliance revenue: $313 million, down 2% Inlyta: $252 million, flat versus the year-ago period Looking ahead: Pfizer reiterated that it expects sales this year to hover around $58 billion to $61 billion, downgraded from an earlier forecast of between $67 billion to $70 billion issued in August. It also expects adjusted earnings will be between $1.45 and $1.65 a share, which had been slashed from a prior range of $3.25 to $3.45 per share.The company said Comirnaty sales are now seen reaching approximately $11.5 billion, down 70% from 2022 results, with Paxlovid set to fall 95% to around $1 billion."With a significant uncertainty removed by our recently announced amended Paxlovid supply agreement with the US government, our expectation of additional clarification on global vaccination and treatment rates by the end of the year, and the breakthroughs continuing to emerge from our pipeline, we look forward to concluding 2023 with positive momentum that showcases Pfizer's long-term growth potential," Bourla said.What analysts said: While the dwindling COVID product sales were "not a huge surprise," BMO Capital Markets analyst Evan Seigerman said "we want to hear more from management on the path to sustainable growth with the Covid reset behind us."Citi analyst Andrew Baum remarked that "the road ahead remains challenging" for Pfizer, noting that in addition to the COVID franchise downturn, the Seagen purchase has potential for "talent-loss post integration."Pipeline update:Pfizer disclosed that its mRNA-based influenza vaccine candidate PF-07252220 achieved both main goals of non-inferiority and superiority, versus a licensed flu shot, for the 18- to 64-year-old cohort of a Phase III trial. It added that secondary immunogenicity endpoints were achieved only for A strains, but not B strains. A Phase III readout for the 65-plus age group is due by year-end. "Given our recent positive results from our next-generation mRNA flu/COVID combination candidate (dubbed PF-07926307) and pending results for our 65-and-older first-generation Phase III standalone mRNA flu study, timing for our standalone mRNA flu is now expected after 2024," said Bourla. "If successful, our next-generation mRNA flu/COVID combination candidate is expected to market in 2025," he added.

VaccineClinical ResultAcquisitionPhase 3

27 Sep 2023

·www.prnewswire.com

Everest Medicines Announces Approval of XERAVA® in Taiwan for the Treatment of Complicated Intra-Abdominal Infections in Adult Patients

SHANGHAI, Sept. 27, 2023 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative medicines and vaccines, announced today that the Taiwan Food and Drug Administration (TFDA) has approved the New Drug Application (NDA) for XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI). "The NDA approval of XERAVA® in Taiwan marks an important step towards bringing this novel, critical therapy for complicated intra-abdominal infections and other life-threatening infections to more patients in Asia," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "Following the successful commercial launch of XERAVA® in mainland China and Singapore, we will accelerate patient access to this product in more markets including Hong Kong and Taiwan." XERAVA® was approved by the National Medical Products Administration ("NMPA") of China in March 2023 and commercially launched in July. It has also been approved and commercialized in Singapore. XERAVA® has been recommended by multiple treatment guidelines in China and globally, based on its broad bacterial spectrum coverage and high potency against multidrug-resistant bacterial infections. Everest entered into an exclusive partnership agreement with TTY Biopharm (TTY) in 2022 for commercialization of XERAVA® in Taiwan. TTY is one of the largest local pharmaceutical companies in Taiwan and has led the successful commercialization of other novel anti-infective products in the region, such as Brosym (cefoperazone+sulbactam), Colistin (colimycin) and Cubicin (daptomycin). About XERAVA® (eravacycline) XERAVA® (eravacycline) is a novel, fully synthetic, broad-spectrum, fluorocycline, parenteral antibiotic of the tetracycline class that has shown broad in vitro activity against Gram-negative, Gram-positive and anaerobic pathogens that have acquired multidrug resistance (MDR) and are prevalent in China. XERAVA® is currently approved for the treatment of complicated intra-abdominal infections (cIAI) in the US, EU, UK, Singapore, mainland China, Hong Kong, and Taiwan. XERAVA® was licensed from Tetraphase Pharmaceuticals, Inc., a wholly owned subsidiary of Innoviva, Inc. About Everest Medicines Everest Medicines is a biopharmaceutical company focused on developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company's core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at . Forward-Looking Statements: This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law. SOURCE Everest Medicines

Drug ApprovalLicense out/in

01 Aug 2023

·firstwordpharma.com

Pfizer's Q2 revenue misses forecasts as COVID product sales recede

Headline results for the second quarter: Revenue: $12.7 billion (forecasts of $13.3 billion), down 54% Profit: $2.3 billion, down 77%Note: All changes are versus the prior-year period unless otherwise statedWhat the company said:Chief financial officer David Denton remarked "the second quarter…delivered solid 5% operational revenue growth, excluding our COVID-19 products, and our year-to-date results are in line with our expectations." However, Denton said that despite expected accelerated growth of non-COVID products in the second half, the company may have to launch a cost-cutting programme if sales of Comirnaty and Paxlovid continue to underperform.According to Pfizer, it anticipates more clarity for COVID revenue in the second half on a likely rise in infections in the fall season and the US switching to a commercial market for the products from government contracts. "To that end, if our COVID-19 revenues are less than what we assumed, we are prepared to launch an enterprise-wide cost improvement programme," Denton explained.Meanwhile, CEO Albert Bourla noted that Pfizer continues "to make progress toward" closing the proposed $43-billion acquisition of Seagen later this year or in early 2024. The executive added that the drugmaker is working to fulfil requests for further information on the transaction from the US Federal Trade Commission.Other results: Primary care sales: $5.8 billion, down 72% Eliquis alliance revenue and direct sales: $1.8 billion, up 1% Comirnaty: $1.5 billion, down 83%, but ahead of forecasts of $1.4 billion Prevnar/Prevenar 13 & 20: $1.4 billion, down 3% Nurtec ODT/Vydura: $247 million Paxlovid: $143 million, down 98%, missing estimates of nearly $1.1 billion Specialty care sales: $3.7 billion, up 9% Vyndaqel/Vyndamax: $782 million, up 42% Xeljanz: $469 million, up 9% Enbrel (outside the US and Canada): $219 million, down 15% Sulperazon: $177 million, down 15% Oxbryta: $77 million Oncology product sales: $3 billion, down 4% Ibrance: $1.2 billion, down 6% Xtandi alliance revenue: $305 million, up 5% Inlyta: $262 million, down 4% Looking ahead:Pfizer now expects revenue for 2023 to be between $67 billion and $70 billion, with the top end lowered by $1 billion from prior guidance. The company reaffirmed that revenue from Comirnaty is seen reaching approximately $13.5 billion, down 64% from 2022, while Paxlovid sales are set to fall 58% to around $8 billion.Meanwhile, Pfizer reiterated that earnings per share for this year are still predicted to be between $3.25 and $3.45, which represents roughly a 50% drop from 2022.Commenting on the recent tornado damage to its manufacturing plant in Rocky Mount, North Carolina, the company said "there does not appear to be major damage to the production areas," with the majority of issues restricted to the warehouse facility. Pfizer indicated that it is working to move finished medicines – which include sterile injectables – to other nearby sites for storage, while it is also exploring alternative manufacturing locations.Pipeline updates:Pfizer disclosed a number of recently-discontinued programmes, led by the mid-stage vaccine PF-06842433 for invasive and non-invasive Pneumococcal infections in infants and children. The cull comprises six Phase I assets, including the topical soft JAK inhibitor PF-07295324 and the CD1a inhibitor PF-07242813, which were both under development for atopic dermatitis.Also on the chopping block were the AXL/MERTK inhibitor PF-07265807 and the IL-15 activator PF-07209960 in oncology, as well as the anti-E-selectin inhibitor PF-07209326 in sickle cell disease and the N-protein inhibitor PF-07923567/RV-299 for respiratory syncytial virus infection.

Phase 1VaccineFinancial StatementAcquisitionClinical Result

100 Deals associated with Cefoperazone Sodium/Sulbactam Sodium

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R&D Status

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Indication	Country/Location	Organization	Date
Bacterial Infections	CN	Zhuhai United Laboratories Co., Ltd.	30 Apr 2004
Infectious Diseases	JP	Pfizer Japan, Inc.	30 Apr 1986

Clinical Result

Indication

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO2018	Not Applicable	Febrile Neutropenia \| Lymphoma	157	Sulbactam-cefoperazone	jaqezbntud(iqqbxklvur) = iiemmsdoph cxcmqpwmwm (vkrssppptt )	Positive	01 Jun 2018
NCT00360607 (Pubmed \| Surg Infect (Larchmt))	Phase 4	Intraabdominal Infections	307	Cefoperazone-sulbactam	dhvnkxmpje(yxlkltaozn) = The incidence of treatment-related adverse events was 6.5% and 16.4% in the cefoperazone-sulbactam and ceftazidime-amikacin-metronidazole groups, respectively, with more discontinuations due to treatment-related adverse events in the comparator arm (3.2% vs. 9.9%) tcohxzxgcb (bglehwnscl )	Positive	01 Jun 2008
NCT00360607 (Pubmed \| Surg Infect (Larchmt))	Phase 4	Intraabdominal Infections	307	Ceftazidime-amikacin-metronidazoleCeftazidime-amikacin-metronidazoleCeftazidime-amikacin-metronidazole		Positive	01 Jun 2008

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