A Comparative Assessment of Clinical, Pharmacological and Antimicrobial Profile of Novel Anti-methicillin-resistant Staphylococcus aureus Agent Levonadifloxacin: Therapeutic Role in Nosocomial and Community Infections

Bakthavatchalam, Yamuna Devi; Rao, Shoma V.; Isaac, Bina; Manesh, Abi; Nambi, Senthur; Swaminathan, Subramanian; Nagvekar, Vasanth; Nangia, Vivek; John, P.; Veeraraghavan, Balaji

doi:10.4103/ijmm.ijmm_20_34

Cited by 16 publications

(14 citation statements)

References 55 publications

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“…Although levonadifloxacin is active against Gram-positive bacteria, it demonstrates potent activity against S. aureus , including the resistant strains such as MRSA, quinolone-resistant S. aureus (QRSA), vancomycin-intermediate S. aureus , and vancomycin-resistant S. aureus . [ 10 ] This is attributable to its unique mechanism of action as compared to other fluoroquinolones, mainly preferential targeting of DNA gyrase ( gyrA ). [ 11 ] Furthermore, levonadifloxacin has a potent cidal activity against MRSA/MSSA intracellularly which was tested in THP-1 macrophages, and hence, both oral and IV levonadifloxacin can offer enhanced therapeutic benefit in treating persistent MRSA infections.…”

Section: Discussionmentioning

confidence: 99%

Prescription-Event Monitoring Study on Safety and Efficacy of Levonadifloxacin (Oral and I.V.) in Management of Bacterial Infections

Mehta¹,

Mehta²,

Sutar³

et al. 2022

International Journal of Applied &Amp; Basic Medical Research

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Background: Levonadifloxacin is a novel broad-spectrum antibiotic belonging to the benzoquinolizine subclass of quinolones. It is available in intravenous as well as oral formulation for the treatment of infections caused by common Gram-positive bacterial pathogens including methicillin-resistant Staphylococcus aureus (MRSA). Patients and Methods: This study retrospectively assessed the real-world safety and efficacy of levonadifloxacin (oral and/or IV) in the treatment of 1229 patients across various clinical conditions. Study outcomes were clinical and microbiological success at the end of therapy. Results: The mean duration of levonadifloxacin therapy was 7.2 days, with a time to clinical improvement averaging at 4 days. Three hundred and three patients received oral therapy, 875 received IV, and 51 received a combination of IV followed by oral therapy. Patients were prescribed levonadifloxacin for skin and soft-tissue infections, diabetic foot infections, septicemia, catheter-related bloodstream infections, bone and joint infections, febrile neutropenia, and respiratory infections including COVID-19 pneumonia. High clinical success rates of 98.3%, 93.7%, and 96.1% with oral, IV, and IV followed by oral levonadifloxacin, respectively, were obtained. Only 11 mild adverse events were reported in 9 patients which included constipation, diarrhea, hyperglycemia, nausea, fatigue, and vomiting. Overall, 96.3% and 97.3% of investigators rated the efficacy and safety of levonadifloxacin as “good to excellent.” Conclusions: An excellent safety and efficacy profile of levonadifloxacin was observed in this study making it a suitable treatment option for management of various bacterial infections, including those caused by resistant Gram-positive pathogens such as MRSA and quinolone-resistant S. aureus .

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Section: Discussionmentioning

confidence: 99%

Prescription-Event Monitoring Study on Safety and Efficacy of Levonadifloxacin (Oral and I.V.) in Management of Bacterial Infections

Mehta¹,

Mehta²,

Sutar³

et al. 2022

International Journal of Applied &Amp; Basic Medical Research

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“…2,5,7,9(13)-tetraene-3-carboxylic acid, the L-alanine ester prodrug of levonadifloxacin (LNF) (WCK 2349) and its Larginine salt (WCK 771) are approved in India for the treatment of ABSSSI, diabetic foot infections (DFI) and concurrent bacteraemia. 23 In 2014, the US FDA granted a status of "qualified infectious disease product (QIDP)" to LNF for the treatment of MRSA infections. 24 Currently, nadifloxacin is being used for the treatment of mild to moderate acne in Japan and other European countries.…”

Section: Structure and Licensing Statusmentioning

confidence: 99%

“…They are effective against gram positive and negative aerobes, gram positive and negative anaerobes and atypical bacteria. 10,23 Figure 3 represents the spectrum of activity of nadifloxacin.…”

Section: Spectrum Of Activitymentioning

confidence: 99%

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Management of skin and soft-tissue infections and acne with topical nadifloxacin: a comprehensive review

Muchhala

Sarkar²,

Lahiri³

et al. 2022

Int J Res Dermatol

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<p class="abstract">Skin and soft tissue infections (SSTIs) and acne are multi-factorial skin conditions that involve microbial invasion of the skin and underlying soft tissues; though, both have different pathogenesis. Most of these infections are caused by bacteria, affecting all age groups. Early diagnosis and appropriate antimicrobial therapy remain the cornerstone of management of SSTIs and acne. Over the years, an increase in antibiotic resistance has been reported with mupirocin and fusidic acid that makes the management of SSTIs and acne increasingly challenging. Further, these antibiotics are unable to penetrate biofilms and show their action on the microorganisms embedded deep in the polymeric matrix. In this review, we have discussed the current evidence on the efficacy and safety profile of nadifloxacin compared to other currently available antimicrobial agents. An extensive search was performed through PubMed and Medline using relevant key words. This article has highlighted nadifloxacin’s broad antimicrobial spectrum, unique dual mechanism of action, distinct characteristics like ability to retain efficacy in acidic pH, low antibiotic resistance and superior action against biofilms. This review concludes that nadifloxacin, could be a potential empirical therapy in the management of SSTIs and acne.</p>

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“…It has also been reported to be active against quinolone-susceptible Gram-negative bacteria and anaerobes. 13,14 Due to high concentrations in lungs, and potent intracellular activity against entire range of potential respiratory pathogens, levonadifloxacin could be well suited for the treatment of respiratory infections caused by extracellular and intracellular pathogens, especially in COVID-19. 15 Also, the emerging clinician-friendly safety profile of levonadifloxacin even in patients with multiple co-morbidities is expected to simplify the treatment of secondary bacterial pulmonary infections in patients with COVID-19 and co-morbidities.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of intravenous and/or oral levonadifloxacin in the management of secondary bacterial pulmonary infections in COVID-19 patients: findings of a retrospective, real-world, multi-center study

Saseedharan

Aneja

Chowti³

et al. 2021

Int J Res Med Sci

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Background: Owing to dysregulated immune response, secondary bacterial pulmonary infections involving both gram-positive and gram-negative pathogens are common in COVID-19 patients and are often associated with higher mortality. This is a first ever report on the safety and efficacy of levonadifloxacin in the treatment of secondary bacterial pulmonary infections in patients with COVID-19 pneumonia.Methods: This multi-center, retrospective, post-marketing and real-world study assessed the safety and efficacy of IV and/or oral levonadifloxacin in the treatment of bacterial infections encountered in COVID-19 patients. Data for 154 male/female patients above 18 years of age who received levonadifloxacin (injectable and/or oral) was collected from 44 participating sites. Study outcomes were the clinical and microbial success at the end of therapy. Safety was assessed based on clinical and laboratory adverse events.Results: Among the 154 patients assessed, 121 (78.6%) were males and 142 (92.2%) were hospitalized. Majority of the patients (119) received all-IV therapy while 11 patients were prescribed with IV followed by oral regimen. All-oral therapy was received by 24 patients. The most common co-morbid conditions were diabetes (19.6%) and hypertension (19.2%). Post-treatment with levonadifloxacin, clinical and microbial success rates were 96.8% and 97.0% respectively.Conclusions: Levonadifloxacin showed promising safety and efficacy when used as IV and/or oral therapy for the treatment of secondary bacterial pulmonary infections in COVID-19 patients. Clinically relevant features of levonadifloxacin such as availability of both IV and oral options, broad spectrum coverage and reassuring safety in patients with significant co-morbidities could help simplify the management.Trial registration no. CTRI/2020/09/028152 [Registered on: 30/09/2020].

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A Comparative Assessment of Clinical, Pharmacological and Antimicrobial Profile of Novel Anti-methicillin-resistant Staphylococcus aureus Agent Levonadifloxacin: Therapeutic Role in Nosocomial and Community Infections

Cited by 16 publications

References 55 publications

Prescription-Event Monitoring Study on Safety and Efficacy of Levonadifloxacin (Oral and I.V.) in Management of Bacterial Infections

Prescription-Event Monitoring Study on Safety and Efficacy of Levonadifloxacin (Oral and I.V.) in Management of Bacterial Infections

Management of skin and soft-tissue infections and acne with topical nadifloxacin: a comprehensive review

Efficacy and safety of intravenous and/or oral levonadifloxacin in the management of secondary bacterial pulmonary infections in COVID-19 patients: findings of a retrospective, real-world, multi-center study

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