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.

Background Community-acquired bacterial pneumonia (CABP) is associated with a substantial healthcare burden. The emergence of multi-drug resistance in  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 14 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 findings, laboratory evaluation, and electrocardiograms (ECGs) collected during the study. Results Of the 101 patients, nine patients did not receive the drug and were excluded from the study. The intent-to-treat (ITT) analysis set consisted of 92 patients out of which 74 patients were included in the modified ITT (mITT) dataset as follow-up data were not available for 18 patients. Of the 74 patients, 51 patients (68.9%) were male, 22 patients (29.7%) were female and one patient (1.4%) was transgender. Of all the patients, 49 (66.2%) patients received oral therapy, eight (10.8%) received IV therapy and 17 (23.0%) received IV therapy followed by oral levonadifloxacin therapy. On the fourth day after the first dose, clinical improvement was reported in 49/74 (66.21%) subjects, and clinical cure was reported in 7/74 (9.45%) patients. At the end of treatment/EOT, clinical cure was reported in 69/71 (97.18%) subjects, and microbiological cure was reported in 67/71 (94.36%) subjects. At test of cure/TOC, clinical cure was reported in 63/63 (100%) subjects. No significant changes in vital parameters, laboratory parameters, or 12-lead ECG were observed with levonadifloxacin therapy during the study. Seven subjects [n=7/92 (7.60%)] were reported to have experienced the AEs during the study period. AEs included nausea, vomiting, myalgia, headache, and rash. All events were mild in severity and resolved without sequelae. Conclusions Levonadifloxacin administered by oral and/or IV route showed promising efficacy and safety outcomes in hospitalized patients or patients receiving outpatient therapy for CABP.