Abstract

Pneumonia is an acute infection of the lung parenchyma distal to the terminal bronchiole, most commonly bacterial in nature, and associated with clinical and/or radiological evidence of consolidation of part or parts of one or both lungs. It remains a cause of considerable morbidity and mortality throughout the world. Mortality is improved by early initiation of antibiotics to which the causative organism(s) are susceptible, and adversely affected by delayed or inappropriate initial therapy. To evaluate the safety and efficacy of solithromycin in subjects suffering with pneumonia. To evaluate the occurrence of relapse.To evaluate the occurrence of superinfection. The trial was a randomized, activecontrolled comparative study which was intended to evaluate the efficacy and safety of Solithromycin in comparison with Zithromax in pneumonia (HAP) caused by β - lactamase (extended spectrum beta lactamase and metallo-beta lactamase) producing gram negative bacteria. Totally 90 evaluable ESBL producing gram negative infection cases were included in the study. Although thiswas a retrospective cohort study, the strict inclusion and exclusion criteria used in this study resulted in two groups thatwere extremely well balanced at baseline. Drawing the study groups from the same time period mitigated any temporalbiases introduced by improvements in clinical care standards. The safety of both drugs were compared and the subjects with azithromycin have experienced more adverse effects. From our study the results suggest that the test drug is greater and safer than the Azithromycin therapy in subjects suffering with pneumonia condition.this is the first study, to the best of our knowledge that has specifically examined the outcomes of empirical Solithromycin versus Azithromycin for patients with severe CAP. The results strongly suggest that Solithromycin therapy increases survival for this severely ill patient group and is safer than the azithromycin. Further study of Solithromycin empirical therapy versus Azithromycin for patients with severe CAP in a prospective, randomized clinical trial with optimal dosages of Solithromycin is warranted based on these results.

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