India-discovered levonadifloxacin & alalevonadifloxacin: A review on susceptibility testing methods, CLSI quality control and breakpoints along with a brief account of their emerging therapeutic profile as a novel standard-of-care.
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Veeraraghavan Balaji, Bakthavatchalam Yamuna Devi, Manesh Abi, Lal Binesh, Swaminathan Subramanian, Ansari Abdul, Subbareddy K, Rangappa Pradeep, Choudhuri Anirban Hom, Nagvekar Vasant, Mehta Yatin, Appalaraju Boppe, Baveja Sujata, Baliga Shrikala, Shenoy Suchitra, Bhardwaj Renu, Kongre Vaishali, Dattatraya Gogi Suresh, Verma Binita, Mukherjee D N, Gupta Shalini, Shanmugam Priyadarshini, Iravane Jyoti, Mishra Sudhi Ranjan, Barman Purabi, Chopra Shimpi, Hariharan Meenakshi, Surpam Rajendra, Pratap Rana, Turbadkar Dilip, Taklikar Shripad, Drug Discovery group, Wockhardt
Аннотация
OBJECTIVE: This review, for the first time, critically analyses the antimicrobial susceptibility testing methods, Clinical Laboratory & Standards Institute (CLSI)-quality control of susceptibility testing and breakpoints of levonadifloxacin. Further, the genesis, discovery and developmental aspects as well as therapeutic profile of levonadifloxacin and alalevonadifloxacin are briefly described.
CONTENTS: In order to aid the scientific and clinician communities with a single comprehensive overview on all the key aspects of levonadifloxacin and alalevonadifloxacin, the present article covers the reference MIC and disk diffusion methods for levonadifloxacin susceptibility testing that were approved by CLSI and the reference ranges for quality control strains published in the CLSI M100 document. The breakpoints of levonadifloxacin were derived in concordance to US FDA, European Committee on Antibiotic Susceptibility Testing (EUCAST) and CLSI approaches. Further, the article provides a brief account of challenges encountered during the discovery stages of levonadifloxacin and alalevonadifloxacin, activity spectrum and safety benefits accruing from structural novelty-linked mechanism of action. Further, the review also covers in vitro and in vivo activities, registrational clinical studies and patient-friendly features of levonadifloxacin/alalevonadifloxacin. Cumulatively, levonadifloxacin has a potential to offer a long awaited new standard-of-care treatment for the resistant Gram-positive bacterial infections.