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

Authors

  • Sanjith Saseedharan Department of Medicine, S. L. Raheja Hospitals, Mumbai, Maharashtra India
  • Pankaj Aneja Department of Diabetes and Metabolic disorders, Max Hospitals, New Delhi, India
  • Aditya Chowti Department of Internal Medicine, Specialist Hospital, Bengaluru, Karnataka, India
  • Khokan Debnath Department of Clinical Operations, PV and Regulatory affairs Wockhardt Ltd., BKC, Mumbai, Maharashtra, India
  • Kapil Dev Mehta Department of Medical Affairs, Wockhardt Ltd., BKC, Mumbai, Maharashtra, India
  • Pramit Sonone Department of Medical Affairs, Wockhardt Ltd., BKC, Mumbai, Maharashtra, India

DOI:

https://doi.org/10.18203/2320-6012.ijrms20213685

Keywords:

COVID-19, Levonadifloxacin, Secondary bacterial infections, Real world study

Abstract

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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Published

2021-09-28

How to Cite

Saseedharan, S., Aneja, P., Chowti, A., Debnath, K., Mehta, K. D., & Sonone, P. (2021). 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. International Journal of Research in Medical Sciences, 9(10), 2933–2939. https://doi.org/10.18203/2320-6012.ijrms20213685

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Original Research Articles