A Prospective, Observational, Open-Label, Non-comparative, Multi-center Study for the Evaluation of Efficacy and Safety of Levonadifloxacin (Intravenous and Oral) in Patients With Community-Acquired Bacterial Pneumonia
Abstract
Background Community-acquired bacterial pneumonia (CABP) is associated with a substantial healthcare burden. The emergence of multi-drug resistance in Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis is becoming an increasing concern in the management of CABP. This study aims to evaluate the efficacy and safety of levonadifloxacin in the treatment of CABP, focusing on both oral and intravenous (IV) therapy. Materials and methods This prospective, post-marketing, multi-center, observational, investigator-initiated real-world study was conducted in adult CABP patients of any sex at eight healthcare facilities (Shree Ashirwad Hospital, Mumbai, Hansa Clinic & Hospital, Daman and Diu, Charak Hospital and Research Centre, Lucknow, Midland Healthcare & Research Centre, Lucknow, Ashirwadh Hospital, Thane, Mahatma Gandhi Medical College and Research Institute, Puducherry, GMERS Medical College and General Hospital, Vadodara, and KD Hospital, Ahmedabad) across India after obtaining written informed consent from the subjects. Basic demographic data including the treatment details were collected. The efficacy was assessed in terms of the clinical outcome on the fourth day after the first dose, at the end of treatment/EOT (seventh day to 14th day after the first dose), and at test of cure/TOC (7±1 days after EOT) as well as microbiological outcome at the EOT. Evaluation of safety was based on adverse events (AEs) reported, vital signs and systemic examination…
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