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
Bibliographic record
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 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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".