Use of Teicoplanin on a Three-weekly Administration in the Complex Outpatient Macroactivity Regimen of Infectious Diseases Unit in the Alessandro Manzoni Hospital (Lecco, Italy)

Teicoplanin is an antibiotic belonging to the class of glycopeptides, in use since 1986. Like its older "classmate" vancomycin, it inhibits protein synthesis by interfering with the synthesis of peptidoglycan, and is active on Gram-positive bacteria such as Staphilococcus spp (including MRSA), Streptococcus spp and Enterococcus spp (both faecalis and faecium).
Teicoplanin is characterized by poor gastrointestinal absorption, which requires intramuscular or intravenous administration; has a binding to plasma proteins greater than 90%; and a high volume of distribution. It reaches high levels in deep tissues (bone, abdomen, lung, kidney, heart) on the contrary it has poor penetration at the central nervous system level; it is approved for the treatment of skin and soft tissue infections, osteo-articular infections, pneumonia, endocarditis, complicated urinary tract infections, peritonitis and bacteremia associated with the aforementioned clinical conditions. Furthermore, teicoplanin has a markedly long half-life (between 30 and 180h) which allows it to be administered even every 48-72h. Dose and duration of treatment should be adjusted according to the location and severity of the infection and based on patient characteristics such as renal function. The possibility of carrying out therapeutic drug monitoring (TDM) allows maintaining plasma levels adequate for the treatment of deep infections (e.g. >20 mg/l for endocarditis) and avoiding overdose.
Thanks to the possibility of administering teicoplanin on a three-weekly schedule, patient access to hospital is further reduced.
The investigators therefore propose a retrospective study to evaluate the clinical effectiveness of teicoplanin therapy according to a three-weekly scheme by comparing its use in the treatment of deep infections (deep seated infections - DSIs) and superficial infections (non-deep seated infections - NDSIs).

开始日期2024-05-07

申办/合作机构-

NCT05914467 / Recruiting临床4期

A Randomized Trial Investigating the Superiority of TDM-optimized Teicoplanin Dosing Versus Standard of Care

Value of TDM for teicoplanin is not well defined. In this single-center low-interventional randomized trial the investigators aim to investigate the superiority of teicoplanin TDM-optimized using Model-Informed-Precision-Dosing (MIPD) of unbound concentrations versus the standard of care (dosing based on antibiotic guidelines) in target attainment.

开始日期2023-08-01

申办/合作机构

Radboud University Medical Center

[+1]

NCT05074147 / Not yet recruiting临床3期

Three Weeks Versus Six Weeks Antibiotic Therapy for Nonsurgically Treated Diabetic Foot Osteomyelitis : a Multicenter, Randomized, Open-label and Controlled Study

The aim of this clinical study is to compare the efficacy and tolerance of 3 versus 6 weeks of antibiotherapy in patients with diabetic foot osteomyelitis treated medically.

开始日期2022-05-01

申办/合作机构

Centre Hospitalier de Tourcoing

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2024-03-04·Journal of burn care & research : official publication of the American Burn Association

The Distribution and the Antimicrobial Susceptibility Features of Microorganisms Isolated From the Burn Wounds: A 10-Year Retrospective Analysis

Article

作者: Çallı, İskan ; Parlak, Mehmet ; Özkaçmaz, Ayşe ; Bayram, Yasemin ; Akış, Feride ; Dicle, Yalçın

Abstract:

In this study, we aimed to evaluate the distribution features and antimicrobial susceptibility test results of the microorganisms isolated from the wounds of pediatric and adult patients with burn. The culture and susceptibility test results of the microorganisms, isolated from the wound swabs of the patients hospitalized in a tertiary-burn care center in 10-year period, were retrospectively screened on the microbiology department databases. Their distribution of isolated microorganisms regarding species and susceptibility test results were compared with previous studies. A total of 367 microorganisms, isolated from the burn wounds of 293 patients (13 ± 18.9 years, F/M: 0.93) (73 adults and 220 pediatric patients), were included in this study. A solitary agent was isolated in 239 (81.6%) patients, while 2 were isolated in 43 (14.7%) and 3 or more agents in 11 (3.8%). From these, 33% of the isolated microorganisms were gram-positive cocci, 61% were gram-negative bacteria, and 6% were Candida spp. The most common isolated microorganisms were Staphylococcus aureus (18.5%), Pseudomonas spp. (16.9%), and Escherichia coli (11.2%), while the least common was Streptococcus spp. (2.5%). Methicillin resistance was 15% among the S. aureus strains. No resistance was observed against levofloxacin, vancomycin, teicoplanin, linezolid, daptomycin, fusidic acid, and tigecycline in S. aureus strains. The highest resistance rates were observed against levofloxacin (64%), tobramycin (64%), pip/tazobactam (63%), imipenem (63%), and the lowest against colistin (5%) and ceftazidime (29%), among Pseudomonas spp. The most common causative agents in burn wound infections and their current antimicrobial susceptibility features should be well identified, in order for prevention of serious complications and optimal management the condition to occur.

2024-03-01·Diagnostic microbiology and infectious disease

Prevalence and molecular characteristics of heterogeneous vancomycin intermediate Staphylococcus aureus in a tertiary care center of northern China

Article

作者: Ma, Liyan ; Sun, Wei ; Cheng, Xin ; Su, Jianrong ; Wang, Yaru

The use of glycopeptide medications may decline in line with the annual decline in methicillin-resistant Staphylococcus aureus (MRSA) detection rates in China. The rate of heterogeneous vancomycin-intermediate Staphylococcus aureus (hVISA)detection may be impacted by this. However, there is currently a dearth of information on the incidence of hVISA in China. This study aims to analyze the recent epidemiology and molecular characteristics of hVISA strains in Beijing, China. A total of 175 non-duplicate MRSA strains from various infection sites were collected from a medical center between January 2018 and May 2023 and underwent molecular typing and susceptibility testing (Vitek2). Vancomycin and teicoplanin MICs were also evaluated by standard broth microdilution method and agar dilution method, respectively. Isolates growing on screening agar (BHIV4 and BHIT5, brain heart infusion agar containing 4 μg/ml vancomycin and 5 μg/ml teicoplanin, respectively) were characterized further by analysis of macro-Etest (MET) and population analysis profiling with area under the curve (PAP-AUC). The proportion of hVISA among MRSA isolates was 8.6 %. BHIT5 could select all hVISA strains while BHIV4 and MET only selected two hVISA strains. Compared with vancomycin- susceptible Staphylococcus aureus (VSSA), hVISA isolates were less susceptible to erythromycin and clindamycin. In addition, hVISA frequency was MIC-independent despite using different detection methods. In total, 11 types of STs, 28 types of spa typing, four types of SCCmec typing, and two types of agr typing were identified and the predominant type in both MRSA and hVISA isolates was ST239-t030-SCCmecIII-agr I. The analysis of biofilm formation, growth, and virulence genes in hVISA strains revealed sparse information. The dataset presented in this study provided the prevalence and molecular characteristics of hVISA in hospital settings and the combination of BHIT5 and PAP-AUC may identify hVISA efficiently. The result of genotyping suggested the genotype of hVISA was mainly consistent with that of local MRSA. Additional studies on the characteristics of hVISA strains were necessary.

2024-03-01·Journal of global antimicrobial resistance

The first vanE-type vancomycin resistant Enterococcus faecalis isolates in Norway – phenotypic and molecular characteristics

Article

作者: Löhr, Iren H ; Hegstad, Kristin ; Sundsfjord, Arnfinn ; Al Rubaye, Mushtaq ; Bjørnholt, Jørgen Vildershøj ; Janice, Jessin

OBJECTIVES:

We aimed to characterize the vanE cluster and its genetic support in the first Norwegian vanE-type isolates and assess genetic relatedness to other vanE isolates.

METHODS:

Two vanE-type vancomycin resistant Enterococcus faecalis (vanE-VREfs) isolates (E1 and E2) recovered from the same patient 30 months apart were examined for antimicrobial susceptibility, genome sequence, vancomycin resistance induction, vanE transferability, genome mutation rate, and phylogenetic relationship to E. faecalis closed genomes and two vanE-VREfs from North America.

RESULTS:

The ST34 E1 and E2 strains expressed low-level vancomycin resistance and susceptibility to teicoplanin. Their vanE gene clusters were part of a non-transferable Tn6202. The histidine kinase part of vanS_E was expressed although a premature stop codon (E1) and insertion of a transposase (E2) truncated their vanS_E gene. The vancomycin resistance phenotype in E1 was inducible while constitutive in E2. E1 showed a 125-fold higher mutation rate than E2. Variant calling showed 60 variants but nearly identical chromosomal gene content and synteny between the isolates. Their genomes also showed high similarity to another ST34 vanE-VREfs from Canada.

CONCLUSION:

In-depth genomic analyses of the first two vanE-VREfs found in Europe identified a single chromosomal insertion site of two variants of vanE-conferring Tn6202. Single nucleotide polymorphism (SNP) and core genome multilocus sequence type (cgMLST) analyses show the genomes are different. This can be explained by the high mutation rate of E1 and acquisition of different mobile genetic elements; thus, we believe the two isolates from the same patient are genetically related. Genome similarities also suggest relatedness between the Canadian and Norwegian vanE-VREfs.

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2024-04-26

·BioSpace

Bruker Further Enhances Clinical Microbiology & Infection Diagnostics Portfolio at ESCMID Global 2024 Conference

New MBT Pathfinder® IVD robot for automated MALDI Biotyper® target preparation New LiquidArray® MTB-XDR panel for simultaneous detection of M. tuberculosis complex bacteria, and their resistances to five WHO-recommended second-line drugs against multidrug-resistant tuberculosis Pending ELITech acquisition has received all regulatory clearances; closing now expected in the second quarter of 2024 BARCELONA, Spain--(BUSINESS WIRE)-- At the ESCMID Global 2024 conference, Bruker is enhancing its innovative diagnostic solutions in microbial identification, antimicrobial susceptibility testing (AST), early sepsis diagnostics, and other infectious disease assays. Simplifying microbiology and infectious disease diagnostics and workflows in the clinical laboratory is a key goal for Bruker in support of earlier and improved patient treatment decisions. This press release features multimedia. View the full release here: MBT Pathfinder® IVD with Feeder IVD (Photo: Business Wire) Microbial identification – towards automated sample preparation The latest MALDI Biotyper® workflow uses MBT Compass HT IVD software to increase throughput up to 600 samples per hour, and automated instrument tuning via IDealTune™. An optional workflow now offers semi-automated sample preparation via the MBT Pathfinder® IVD robot to avoid time-consuming, repetitive and error-prone manual tasks. Sepsis – when every minute counts When the correct antibiotic treatment for sepsis is given quickly, outcomes can improve dramatically. The IVD-CE MALDI Biotyper®, used in conjunction with the MBT Sepsityper® IVD Kit, can identify pathogens within 20 minutes from a positive blood culture bottle. Bruker offers additional clinical workflows for rapid functional antibiotic resistance testing, like the MBT STAR®-Carba IVD assay for the detection of carbapenemase activity. Antimicrobial susceptibility testing (AST) AST can indicate which antimicrobial regimen is effective for patients. Bruker’s UMIC® tests deliver accurate results for single antibiotics and combinations, and the MICRONAUT range offers AST of multiple antibiotics in a single test in a user-friendly workflow in compliance with CLSI/EUCAST recommendations. The UMIC® portfolio covers five antibiotics and combinations, namely colistin, piperacillin-tazobactam, vancomycin/teicoplanin, daptomycin and cefiderocol. In addition, Bruker is developing the new MBT-fAST assay for rapid AST of gram-negative bacteria from positive blood cultures directly on the MALDI Biotyper® platform. The MBT-fAST clinical studies are planned for the second half of 2024. Bruker also intends concurrent clinical studies for IVDR certification of lipid A-based colistin resistance detection. This and the on-going development of microbial species and subspecies differentiation based on lipid patterns will further enhance the value of the MALDI Biotyper® sirius system for clinical laboratories. The MALDI Biotyper® sirius stands out as the first MALDI-TOF mass spectrometry system for microbial identification that uses the negative ion mode for microbial lipid analysis. Currently, this feature is for Research Use Only (RUO), setting the stage for forthcoming clinical applications. Outbreak control The Bruker IR Biotyper® enables efficient microbial strain typing of bacteria and yeasts for real-time epidemiological surveillance for a range of disease-causing pathogens. During outbreak scenarios within hospitals, the IR Biotyper can help prevent the spread of hospital-acquired infections (HAI). The IR Biotyper® for hospital hygiene and infection control can be combined with the MALDI Biotyper® for microbial species identification. LiquidArray® – next-generation syndromic panels The new LiquidArray® Gastrointestinal syndromic panel facilitates the simultaneous detection of up to 26 pathogens responsible for gastroenteritis. This streamlines clinical decision-making by allowing the simultaneous analysis of multiple targets from a single sample. The rise of multidrug-resistant and extensively drug resistant M. tuberculosis strains has added complexity to TB diagnosis and treatment – and global travel is causing re-emergence in formerly low risk countries. Bruker’s new multiplex mycobacteria test LiquidArray® MTB-XDR VER 1.0, detects TB-causing bacteria of the M. tuberculosis complex and identifies resistance to five WHO-recommended second-line drugs. Dr. Wolfgang Pusch, President of the Bruker Microbiology & Infection Diagnostics division, commented: “Bruker is committed to innovation in routine microbiology and infectious disease testing. This includes nearly universal microbial identification with the MALDI Biotyper®, rapid blood culture analysis with the MBT Sepsityper® IVD Kit, early implementation of diagnostics for new antibiotics with our UMIC® portfolio, real-time epidemiological surveillance with the IR Biotyper®, and syndromic panels with our LiquidArray® assay portfolio.” Pending ELITechGroup Acquisition Regulatory Clearances As announced on February 28, 2024, Bruker Corporation has signed a Share Purchase Agreement to acquire ELITechGroup, excluding the ELITech clinical chemistry business. All regulatory clearances for this acquisition have now been received, and closing of the acquisition is expected during Q2 2024, subject to remaining closing conditions. About Bruker Corporation – Leader of the Post-Genomic Era (Nasdaq: BRKR) Bruker is enabling scientists and engineers to make breakthrough post-genomic discoveries and develop new applications that improve the quality of human life. Bruker’s high performance scientific instruments and high value analytical and diagnostic solutions enable scientists to explore life and materials at molecular, cellular, and microscopic levels. In close cooperation with our customers, Bruker is enabling innovation, improved productivity, and customer success in post-genomic life science molecular and cell biology research, in applied and biopharma applications, in microscopy and nanoanalysis, as well as in industrial and cleantech research, and next-gen semiconductor metrology in support of AI. Bruker offers differentiated, high-value life science and diagnostics systems and solutions in preclinical imaging, clinical phenomics research, proteomics and multiomics, spatial and single-cell biology, functional structural and condensate biology, as well as in clinical microbiology and molecular diagnostics. For more information, please visit . View source version on businesswire.com: Contacts Trade Press & Customer Contact: Philip Perry Senior Vice President, Marketing and Product Management Bruker Microbiology & Infection Diagnostics Division T: +49-172-313-7216 E: philip.perry@bruker.com Investor Contact: Justin Ward Sr. Director, Investor Relations & Corporate Development Bruker Corporation T: +1 (978) 313-5800 E: Investor.Relations@bruker.com Source: Bruker Corporation Smart Multimedia Gallery Photo MBT Pathfinder® IVD with Feeder IVD (Photo: Business Wire) Photo LiquidArray® MTB-XDR VER 1.0 (Photo: Business Wire) Logo View this news release and multimedia online at:

并购

2024-03-15

·FiercePharma

EuroAPI's troubles mount as audit reveals manufacturing lapses in Italy, spurring 2024 guidance suspension

As EuroAPI investigates the situation, production at its Italian facility in Brindisi will remain suspended until further notice. Beleaguered Sanofi spinout EuroAPI can’t seem to catch a break. After reporting ballooning losses and a four-year restructuring plan last month, the company revealed Thursday that manufacturing lapses at an Italian plant have temporarily derailed its guidance for the year. EuroAPI’s Italian subsidiary is suspending production of all active pharmaceutical ingredients (APIs) at its plant in Brindisi after an internal audit uncovered quality control deficiencies “due to potential local misconduct,” the company said in a release. As the manufacturer investigates the situation, production at the facility will remain suspended until further notice, EuroAPI added. The situation is likely to weigh on the company's operational and financial performance for 2024, EuroAPI warned, so it's suspending its guidance for the year. A revised 2024 outlook is being planned for release in the year’s second quarter. The Brindisi site produces 11 APIs and intermediates, which primarily consist of anti-infectives including spiramycin, rifaximin, rifampicin and teicoplanin. Last year, sales from the Italian facility clocked in at 63 million euros (around $69 million). While sales from the site are "limited," the production lapse could have an “image impact” on the company in relation to its clients, ODDO BHF analysts wrote to clients. Given the evolving situation at EuroAPI, the ODDO team has slashed 52 million euros from its topline forecast for the company and is now predicting a sales decline of 11%, versus the 6% revenue slump the analysts had previously projected. Since EuroAPI’s market debut as a standalone API maker and CDMO in May 2022, the company has encountered numerous hurdles that have threatened its goal to become a “partner of choice for all pharmaceutical and biotech companies.” Last month, in tandem with the company’s 2023 earnings report, EuroAPI appointed a new CEO and unveiled a four-year restructuring scheme dubbed FOCUS-27, which will involve streamlining the company’s API portfolio, focusing its CDMO activities, rationalizing its industrial footprint and becoming an altogether “leaner organization.” Naturally, potential layoffs are a part of the plan, which could see job cuts across “all functions” at the company, including industrial operations, quality, R&D and support roles. As part of the plan, EuroAPI said at the time that its attempt to focus on higher-value APIs could result in potential sales of its sites in Brindisi, Italy, and Haverhill, England. As the ODDO BHF team sees it, the transformation and restructuring costs under FOCUS-27 could be “made worse” now that EuroAPI will need to get its Brindisi plant up to standard before a potential sale. For all of 2023, EuroAPI reported net sales growth of 4% to 1.01 billion euros (about $1.09 billion). The company logged a net loss of 189.7 million euros.

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2024-03-14

·GlobeNewswire-Health Care

Full-year 2024 guidance suspended due to the temporary pause of API production at the Brindisi site in Italy

Press Release Paris – March 14th, 2024 – EUROAPI today announces that its Italian subsidiary, EUROAPI Italy S.R.L., is suspending the production of all APIs1 in Brindisi. Following an internal audit, quality control deficiencies due to potential local misconduct have been identified and are being further investigated. Production will remain suspended until further notice. The relevant health authorities have been informed. The company has initiated a forensic audit and will inform its customers. The Brindisi site produces 11 APIs and intermediates, mostly anti-infectives (including spiramycin, rifaximin, rifampicin and teicoplanin). In 2023, sales related to the Brindisi site amounted to 63 million euros, of which 43% related to Sanofi. The value of Brindisi non-current assets has been fully impaired in 2023 Consolidated Accounts. This situation is expected to impact the Group's operational and financial performance. Consequently, the full-year 2024 guidance is suspended. A revised full-year 2024 outlook will be provided in Q2 2024, along with the planned communication on the implementation and the financing of the FOCUS-27 project announced on February 28th, 2024. Conference call today at 07:45 PM CET EUROAPI management will hold a live audio webcast today at 07:45 PM CET (https://channel.royalcast.com/landingpage/euroapi-eng/20240314_1/). To participate in the Q&A session, please dial in the following numbers: France: +33 (0) 1 70 37 71 66UK: +44 (0) 33 0551 0200US: +1 786 697 3501 Media Relations contact:Laurence BollackTel.: +33 (0)6 81 86 80 19mr@euroapi.com Investor Relations contact:Sophie Palliez-CapianTel.: +33 (0)6 87 89 33 51Sophie.palliez@euroapi.com Camile RicotierTel : +33 (0)6 43 29 93 79Camille.ricotier@euroapi.com Financial Calendar March 26th, 2024: Publication of the 2023 Universal Registration Document May 22nd, 2024: Annual Shareholder General MeetingQ2 2024: Further information on FOCUS-27 projectJuly 31st, 2024 (before market opening): H1 2024 Results About EUROAPI EUROAPI is focused on reinventing active ingredient solutions to sustainably meet customers’ and patients’ needs around the world. We are a leading player in active pharmaceutical ingredients with approximately 200 products in our portfolio, offering a large span of technologies while developing innovative molecules through our Contract Development and Manufacturing Organization (CDMO) activities.Taking action for health by enabling access to essential therapies inspires our 3,450 people every day. With strong research and development capabilities and six manufacturing sites, all located in Europe, EUROAPI ensures API manufacturing of the highest quality to supply customers in more than 80 countries. EUROAPI is listed on Euronext Paris; ISIN: FR0014008VX5; ticker: EAPI). Find out more at www.euroapi.com and follow us on LinkedIn. Forward-looking statements Certain information contained in this press release is forward looking and not historical data. These forward-looking statements are based on opinions, projections and current assumptions including, but not limited to, assumptions concerning the Group’s current and future strategy, financial and non-financial future results and the environment in which the Group operates, as well as events, operations, future services or product development and potential. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Forward looking statements and information do not constitute guarantees of future performances, and are subject to known or unknown risks, uncertainties and other factors, including social risks, a large number of which are difficult to predict and generally outside the control of the Group, which could cause actual results, performances or achievements, or the results of the sector or other events, to differ materially from those described or suggested by these forward-looking statements. These risks and uncertainties include those that are indicated and detailed in Chapter 3 “Risk factors” of the Universal Registration Document approved by the French Financial Markets Authority (Autorité des marchés financiers, AMF) on April 14, 2023, under number R.23-009 and the Amendment to Universal Registration Document approved by the AMF on April 25, 2023 under number R.23-015 (which are both available at www.euroapi.com). These forward-looking statements are given only as of the date of this press release and the Group expressly declines any obligation or commitment to publish updates or corrections of the forward-looking statements included in this press release in order to reflect any change affecting the forecasts or events, conditions or circumstances on which these forward-looking statements are based.” 1 API : Active Pharmaceutical Ingredients Attachment EUROAPI press release - March 14, 2024

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KEGG	Wiki	ATC	Drug Bank
D02142	替考拉宁	J01XA02	DB06149

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适应症	国家/地区	公司	日期
脓胸	日本	Sanofi	1998-04-10
出血性败血症	日本	Sanofi	1998-04-10
肺炎	日本	Sanofi	1998-04-10
皮肤和皮肤结构感染	日本	Sanofi	1998-04-10
皮肤疾病	日本	Sanofi	1998-04-10
革兰氏阳性细菌感染	中国	Gruppo Lepetit SRL	-

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囊性纤维化	临床1期	意大利	苏州润新生物科技有限公司	2019-10-25

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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


NCT01592032 (Pubmed \| J Microbiol Immunol Infect)	临床4期	菌血症	44	Teicoplanin lock therapy	鹹淵構顧觸願鑰壓淵願(廠襯餘醖廠廠獵製遞鹹) = 鹽觸艱齋鑰襯廠遞鏇選簾蓋艱壓顧觸襯範壓獵 (選窪餘夢獵觸製鹹範餘 ) 更多	积极	2009-11-01
				Vancomycin lock therapy	鹹淵構顧觸願鑰壓淵願(廠襯餘醖廠廠獵製遞鹹) = 壓選淵夢範蓋構遞醖壓簾蓋艱壓顧觸襯範壓獵 (選窪餘夢獵觸製鹹範餘 )