Safety and efficacy of a novel drug elores (ceftriaxone + sulbactam + disodium edetate) in the management of multi-drug resistant bacterial infections in tertiary care centers: a post-marketing surveillance study

Abstract Objective: In India, Elores (CSE-1034: ceftriaxone + sulbactam + disodium edetate) was approved as a broad spectrum antibiotic in year 2011 and is used for management of Extended Spectrum Beta Lactamases/Metallo Beta lactamases infections in tertiary care centers. The objective of this study was to investigate the efficacy of this drug in patients with Extended Spectrum Beta Lactamases/Metallo Beta lactamases infections and identify the incidence of adverse events in real clinical settings. Methods: This Post Marketing Surveillance study was conducted at 17 centers across India and included 2500 patients of all age groups suffering from various bacterial infections and treated with Elores (CSE1034). Information regarding demographic, clinical and microbiological parameters, dosage and treatment duration, efficacy and adverse events (AEs) associated with the treatment were recorded. Results: A total of 2500 patients were included in the study and efficacy was evaluated in 2487 patients. In total, 409 AEs were reported in 211 (8.4%) patients. The major AEs reported were vomiting (3.0%), pain at injection site (2.5%), nausea (2.3%), redness at site (1.96%), thrombophlebitis (1.4%). Of total reported AEs, 40 (5.3%) AEs were reported in pediatric, 310 (20.6%) in adult, and 59 (23.6%) in geriatric group. No AE belonging to grade IV or V was reported in any patient. In terms of efficacy, 1977 (79.4%) patients were cured, 501 (20.1%) patients showed clinical improvement and 5 (0.2%) patients were complete failure. The treatment duration varied from 5 to 7 days in different patients depending on the infection type. Conclusion: In this post-marketing surveillance study, CSE-1034 was found to be an effective and safe option against Pip tazo and meropenem in management of patients with multi-drug resistant (MDR) bacterial infections under routine ward settings.

A New Fixed Dose Combination of Ceftriaxone + Sulbactam + Disodium Edetate for Definitive Treatment of Infections Due to Piperacillin/ Tazobactam Resistant Bacteria: A Retrospective Efficacy and Pharmacoeconomic Study.

Objective: Present retrospective study was aimed to analyze comparative efficacy of fixed dose combination (FDC) (ceftriaxone + sulbactam + disodium edetate) and meropenem used alone or in combinations with other antibiotics for management of intensive care unit (ICU) patients suffering with infections from piperacillin-tazobactam (pip-taz) resistant bacteria and to assess the costs associated with respective therapies. Methodology: Patients records were collected and their demographic characteristics, infection types, co-morbidities, antibiotic therapy, dosage, treatment duration microbial and clinical success rates were evaluated. Effectiveness and costs analysis between antibiotic regimens were estimated in Indian rupees (INR). A total of 136 patients data treated at a tertiary-care hospital was analyzed. These 136 patients included 28, 18, 19, 17, 31 and 23 patients of urinary tract infection (UTI), blood stream infection (BSI), community acquired infection (CAI), skin structure infection (SSI), intra-abdominal infection (IAI) and ventilator associated pneumonia (VAP), respectively. Out of 136 patients, 56 patients received FDC and another 80 patients were administered with meropenem empirically. Results: Clinical cure observed was 71.42% and 67.50% in FDC and meropenem groups, respectively. The patients in whom meropenem and FDC treatment regime failed to show improvement, colistin was given as an additional cover, which resulted in clinical cure of 86.95% and 85.71% patients respectively. Comparative cost expenditure analysis of these two drug treatment regimens revealed that, the overall treatment cost for patients cured with antibiotic regimen containing meropenem was 107.39% more than that of FDC. The strongest contributors of the increase in treatment costs were cost of antibiotic, number of dosages, average treatment duration and clinical failure rates. Conclusion: Infections with pip-taz resistant bacteria are frequent in ICU patients and the present study demonstrates that FDC has comparatively similar efficacy as that of meropenem which is considered as an appropriate option to treat pip-taz resistant cases. Pharmacoeconomic analysis clearly advocates in favor of FDC as a cheaper and safer alternative to meropenem to treat ICU patients with infections caused due to pip-taz resistant bacteria.