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
Notice bibliographique
Résumé
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.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,004 | 0,004 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,001 | 0,001 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,001 | 0,000 |
| Intégrité de la recherche | 0,001 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,002 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».