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).

Start Date07 May 2024

Sponsor / Collaborator-

NCT05914467 / RecruitingPhase 4IIT

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.

Start Date01 Aug 2023

Sponsor / Collaborator

Radboud University Medical Center

[+1]

ChiCTR2300071179 / SuspendedNot ApplicableIIT

Population Pharmacokinetics of Teicoplanin in Hypoalbuminemia Population

Start Date06 May 2023

Sponsor / Collaborator

Nanjing Drum Tower Hospital

100 Clinical Results associated with Teicoplanin

100 Translational Medicine associated with Teicoplanin

100 Patents (Medical) associated with Teicoplanin

4,017

Literatures (Medical) associated with Teicoplanin

01 Dec 2024·THERAPEUTIC DRUG MONITORING

Optimal Teicoplanin Trough Concentration With Therapeutic Drug Monitoring in Children: A Systematic Review and Meta-analysis

Article

Author: Ueda, Takashi ; Oda, Kazutaka ; Uekusa, Shusuke ; Nishimura, Koji ; Murakami, Lisa ; Hanai, Yuki ; Matsumoto, Kazuaki ; Ohashi, Hayato ; Takesue, Yoshio ; Matsuo, Kazuhiro

Background::

Teicoplanin is used to treat serious Gram-positive bacterial infections. However, the optimal trough concentrations for pediatric patients remain unclear owing to the lack of monitoring guidelines. This study aimed to determine the optimal teicoplanin trough concentration for treating Gram-positive bacterial infections in children.

Methods::

A systematic review was conducted using 4 databases. Stepwise cutoffs within the range of 10–30 mcg/mL were used for efficacy and safety. Studies were included if they reported treatment success rates and/or all-cause mortality, nephrotoxicity, hepatotoxicity, and thrombocytopenia according to the trough concentration.

Results::

The meta-analysis included 12 studies involving 830 pediatric patients. Teicoplanin cutoff values of 10, 15, 20, and 30 mcg/mL were reported in 9, 8, 9, and 2 studies, respectively. Trough concentrations <10 mcg/mL significantly reduced the treatment success rate, with an odds ratio of 0.07 and a 95% confidence interval ranging from 0.01 to 0.40. The overall treatment success rate was 50.0% versus 95.7% observed at concentrations ≥10 mcg/mL. However, no significant difference was observed at the 15-, 20-, and 30-mcg/mL cutoffs, when compared with lower concentrations. Trough concentrations <20 mcg/mL were associated with a decreased risk of nephrotoxicity (odds ratio = 0.21; 95% confidence interval, 0.08–0.55). However, hepatotoxicity and thrombocytopenia showed no significant associations with trough concentration ranges between 10 and 30 mcg/mL.

Conclusions::

Although further prospective studies are required for validation, the authors' findings suggest that 10- to 20-mcg/mL teicoplanin is the optimal trough concentration for enhanced clinical success and reduced toxicity in pediatric patients.

01 Dec 2024·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Chiral superficially porous stationary phases for enantiomeric separation of condensed 1,4-dihydropyridine derivatives

Article

Author: Armstrong, Daniel W ; Burk, Ryan Jacob ; Salehi, Reza ; Gündüz, Miyase Gözde ; J, Siddharth Jaya Sajeevan ; Berthod, Alain ; Armstrong, Daniel W.

1,4-dihydropyridine (DHP) scaffold occupies a prominent position among all heterocyclic compounds owing to its versatile pharmacological properties, particularly its well-known calcium channel blocking activity. In the quest of developing new calcium channel blockers, fifty seven 5-oxo-hexahydroquinoline (HHQ) derivatives carrying DHP framework in a condensed ring system were recently synthesized as racemic mixtures. Due to their potential as drug candidates, enantiomers arising from the asymmetric center at the C-4 position of the HHQ ring were separated. Four modern columns packed with 2.7 µm superficially porous particles bonded with a chiral selector were used. The chiral selectors were three macrocyclic glycopeptide selectors: vancomycin, teicoplanin, and a macrocyclic derivative called nico. The fourth bonded selector was the dinitrobenzamido-tetrahydrophenanthrenyl derivative called Whelko. The four chromatographic modes were assayed with the mobile phase compositions: reversed phase with acetonitrile/buffer 30/70 %v/v, normal phase with hexane/ethanol 80/20 %v/v, and subcritical fluid chromatography with CO₂/methanol 80/20 %v/v at 25 °C. The WhelkoShell column was the most effective in separating this set of 57 compounds. Several enantioresolution factors passed 20 with enantioselectivity ratios higher than 4. Molecular modeling showed that the compounds had a T-shape that fitted well the molecular structure of the WhelkoShell selector in the normal or subcritical modes. Additionally, seven compounds had a second chiral center. The NicoShell column was able to separate all four stereoisomers of these compounds in the reversed phase mode. The preparative production of pure enantiomers of these compounds would be straightforward using the WhelkoShell column in the subcritical mode.

16 Nov 2024·Critical reviews in analytical chemistry

Macrocyclic Antibiotics as Effective Chiral Selectors in Liquid Chromatography for Enantiomeric Separation of Pharmaceutical Compounds: A Review

Review

Author: Alzarak, Tasneem M. ; Fouad, Ali ; Mahmoud, Abdelrahman ; Salman, Basma E. ; El-Sayed, Doaa H. ; Adel, Shahd E. ; Bakr, Hanan H.

Chiral separation techniques play a crucial role in the pharmaceutical industry, where the enantiomeric purity of drugs can have a significant impact on their efficacy and safety. Macrocyclic antibiotics are highly effective chiral selectors used in various chiral separation techniques, including LC, HPLC, SMB, and TLC, offering reproducible results and a wide range of applications. However, developing robust and efficient immobilization mechanisms for these chiral selectors remains a challenge. This review article focuses on various immobilization approaches, such as immobilization, coating, encapsulation, and photosynthesis, that have been applied to immobilize macrocyclic antibiotics on their support. Commercially available macrocyclic antibiotics for conventional liquid chromatography include Vancomycin, Norvancomycin, Eremomycin, Teicoplanin, Ristocetin A, Rifamycin, Avoparcin, Bacitracin, and others. In addition, capillary (nano) liquid chromatography has also been used in chiral separation utilizing Vancomycin, Polymyxin B, Daptomycin, and Colistin Sulfate. Macrocyclic antibiotic-based CSPs have been extensively applied due to their reproducible results, ease of use, and broad range of applications, capable of separating a large number of racemates.

News (Medical) associated with Teicoplanin

26 Apr 2024

·www.biospace.com

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:

Acquisition

15 Mar 2024

·www.fiercepharma.com

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.

Financial Statement

14 Mar 2024

·www.globenewswire.com

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

100 Deals associated with Teicoplanin

External Link

KEGG	Wiki	ATC	Drug Bank
D02142	Teicoplanin	J01XA02	DB06149

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Empyema	JP	Sanofi	10 Apr 1998
Hemorrhagic Septicemia	JP	Sanofi	10 Apr 1998
Pneumonia	JP	Sanofi	10 Apr 1998
Skin and skin structure infections	JP	Sanofi	10 Apr 1998
Gram-Positive Bacterial Infections	CN	Gruppo Lepetit SRL	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Cystic Fibrosis	Phase 1	IT	Suzhou NeuPharma Co., Ltd.	25 Oct 2019
Cystic Fibrosis	Phase 1	IT	Neupharma Srl	25 Oct 2019
Hemorrhagic Fever, Ebola	Preclinical	CN	Sun Yat-Sen University	01 Apr 2016
Severe Acute Respiratory Syndrome	Preclinical	CN	Sun Yat-Sen University	01 Apr 2016

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01592032 (Pubmed \| J Microbiol Immunol Infect)	Phase 4	Bacteremia	44	Teicoplanin lock therapy	gogqcvijth(hmyiszhnvg) = gbmkdhlpyh qnmhfyfkfv (dlvzweytmz ) View more	Positive	01 Nov 2009
				Vancomycin lock therapy	gogqcvijth(hmyiszhnvg) = ozgnyjrqgr qnmhfyfkfv (dlvzweytmz )

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