Efficacy and Tolerability of Meroplan S (Meropenem 1 g and Sulbactam 0.5 g) (ETIOS) in the Management of Lower Respiratory Tract Infections caused by Gram-negative Pathogens in Adults: A Post Marketing Observational Study.

ABSTRACT

Background: The rapid and ongoing spread of antimicrobial-resistant bacteria throughout all healthcare institutions is considered a critical medical and public health issue. Gram-negative bacteria are resistant to multiple drugs and are increasingly resistant to most available antibiotics. Given the high mortality rates caused by drug-resistant Gram-negative bacteria such as Klebsiella, Acinetobacter, Pseudomonas aeruginosa and Escherichia coli and the difficulty of developing new potent antibiotics to target the problematic pathogens, combination regimens are under ardent evaluation as new strategies to overcome increasing drug resistance. Carbapenems such as meropenem have assumed an important antibiotic niche for therapy of various multidrugresistant Gram-negative infections with good safety profile. However, the percentage of carbapenem-resistant enterobacteriaceae (CRE) increased by 4-fold over the last decade and that one particular form of CRE, a resistant form of Klebsiella pneumoniae, has increased 7-fold. Extended-release beta-lactamases (ESBL) production is one of the main bacterial resistance mechanisms to carbapenem antibiotics. The use of ESBL inhibitors like sulbactam combined with carbapenem antibiotics allows the inactivation of ESBLs produced by Gram-negative pathogens. Additionally, sulbactam has an intrinsic antimicrobial activity against penicillin binding proteins. By restoring or expanding the activity of meropenem, the combination with sulbactam offers a new approach to the management of lower respiratory tract infections caused by Gram-negative pathogens. A post marketing observational study was undertaken to evaluate the efficacy and tolerability of (Meropenem 1 g and Sulbactam 0.5 g) injection in the management of lower respiratory tract infections caused by Gram-negative pathogens in adults.