Search

Introduction: This study analyzes the safety and efficacy results of the Indian population subset from the RECLAIM trial investigating the noninferiority of Ceftazidime-Avibactam (CAZ-AVI) plus metronidazole to meropenem and interprets its relevance. Methodology: The study design, subjects inclusion criteria, dosage, safety and efficacy evaluations in Indian patients have been followed as per the RECLAIM trial protocol. Results: A total of 142 Indian patients with complicated intra-abdominal infection were enrolled across eight centers in India, 125 of them were randomized to either CAZ-AVI + metronidazole (n = 62) or meropenem (n = 63) group. the clinical cure rates in modified intention-to-treat (MITT; all randomized patients who met minimum disease requirements and received any amount of study drug) and clinically evaluable (CE, patients who had an evaluable assessment and no protocol deviations) analysis sets, was numerically comparable to the results of overall population for CAZ-AVI + metronidazole [MITT: 82.5% (Overall, n = 429/520) versus 89.3% (Indian, n = 50/56); CE: 91.7% (Overall, n = 376/410) versus 97.8% (Indian, n = 45/46)] and meropenem [MITT: 84.9% (Overall, n = 444/523) versus 84.7% (Indian, n = 50/59); CE: 92.5% (Overall, n = 385/416) versus 95.5% (Indian, n = 42/44)]. No new safety findings were reported in the Indian population. Conclusions: CAZ-AVI + metronidazole proved to be an effective option for critical patients with complicated intra-abdominal infection and can be considered as an alternative to carbapenems in the ICU setting for the treatment of resistant pathogens. [ABSTRACT FROM AUTHOR]

Introduction: Increasing awareness and practice of Antimicrobial Stewardship (AMS) has gained immense importance in Indian hospitals for preventing the irrational use of antibiotics. India is one of the world's largest consumers for antibiotics. Assessment of the local Knowledge, Attitude and Practices (KAP) of Antimicrobial Resistance (AMR) and AMS among Healthcare Providers (HCPs) will help in designing effective public health policies and engaging the community in campaigns against increasing microbial resistance. Aim: To understand the status of AMS programs and practices in five private sector multispecialty hospitals situated in the East, West, North and South zones of the country and to assess the KAP of HCPs regarding AMR and AMS. Materials and Methods: The cross-sectional survey was conducted to assess the implementation of AMS in five hospitals among clinicians, nurses and pharmacists across India using a pre-developed AMS checklist between June 2019 and October 2019. The Analysis was done between July and August 2020. Responses were collected using a five-point Likert scale, with choices ranging from 'strongly agree' to 'strongly disagree'. Descriptive analysis was done for the KAP survey to determine the percentages of participants under each response category. Results: Total 32 clinicians, 55 nurses and eight pharmacists responded to the KAP survey (100% response rate). The clinicians were aware that AMR is caused by irrational prescribing of antimicrobials (n=31, 96.87%) and improper diagnosis of infective conditions (n=27, 84.37%). However, knowledge of clinicians on infection control practices (n=6, 18.75% disagreed) in controlling AMR and practice of referring local epidemiology before prescribing antimicrobials (n=7, 21.87% did not follow routinely) could be improved. The knowledge and practice of nurses and pharmacists on antibiotic use were spread over a wide range. According to the nurses, AMR was mainly caused by using antimicrobials for nonbacterial infections (n=30, 54.54%) and deviations from their standard duration (~63.64%-72.73%). As per pharmacists, the lack of restrictions on antimicrobial usage and widespread use or overuse of antibiotics were major contributors to AMR (n=3, 37.5% strongly agreed). Both nurses and pharmacists could benefit from reinforced training on antibiotic usage. Conclusion: Implementation of AMS was not adequate in private Indian hospitals. Although clinicians have good knowledge on antibiotic use, it was not equally reflected in their practice. The KAP data of nurses and pharmacists suggest that training and education on appropriate antibiotic usage should be emphasised. More efforts are required to improve AMS practices in hospitals. [ABSTRACT FROM AUTHOR]

Introduction: Tigecycline Evaluation and Surveillance Trail (TEST) study is an on-going global surveillance. The study was performed to determine the susceptibility of common pathogens to tigecycline and comparator antibiotics by broth microdilution (BMD) at two tertiary care centres in India from 2015 to 2017. Methodology: Total of 989 isolates collected from various clinical specimens between January 2015 and September 2017 from two centres in India were included. BMD was performed to determine the minimum inhibitory concentration (MIC) for tigecycline and comparator antibiotics. Results: Among Gram-negative bacteria, susceptibility to tigecycline was lowest among Klebsiella spp. being 84% while others such as E. coli, Enterobacter spp., Serratia spp. and H. influenzae showed susceptibility of 98%, 95%, 98% and 100% respectively. Overall, 99 isolates among Enterobacteriaceae (E. coli, Klebsiella spp. and Enterobacter spp.) were ESBL producers, susceptible to tigecycline. Among the 101 meropenem resistant Enterobacteriaceae, 85 were susceptible to tigecycline (84%). Among the Gram-positive bacteria, S. aureus and Enterococcus spp. were 99% and 98% susceptible to tigecycline respectively. Among 68 MRSA isolates in the study, 66 (97%) were susceptible to tigecycline. Seven vancomycin resistant E. faecalis were isolated and all were susceptible to tigecycline. Conclusion: Tigecycline has retained activity over both Gram-positive and Gram-negative organisms with MIC values comparable to global reports. About 98% of the MDR Gram-positive and Gram-negative bacteria in the study are susceptible to tigecycline. With increased incidence of extensively drug resistant organisms, tigecycline is a potential reserve drug. [ABSTRACT FROM AUTHOR]

ATLAS (Antimicrobial Testing Leadership and Surveillance) detects trends in multi-drug resistance longitudinally over time. In the present study, the in vitro activity of ceftazidime-avibactam and comparators was analyzed against Escherichia coli (n = 458) and Klebsiella pneumoniae (n = 455) isolates obtained from 9 centers across India. The overall susceptibility to ceftazidime-avibactam was observed to be 72% among K. pneumoniae isolates and 87% among E. coli isolates. Among the tested carbapenem resistant isolates, 51% of CR- K. pneumoniae and 24% of CR- E. coli were susceptible to ceftazidime- avibactam. OXA-48 like was identified in 52% of the K. pneumoniae isolates followed by co-production of NDM with OXA-48 like in 27%. NDM was predominantly identified in 68% of the E. coli isolates followed by OXA-48 like in 24% isolates. The findings suggest that ceftazidime- avibactam is a reasonable alternative to standard therapy for management of carbapenem resistant Enterobacterales infections particularly with K. pneumoniae and E. coli with the OXA-48 like genotype. [ABSTRACT FROM AUTHOR]

The efficacy and safety of Ceftazidime-Avibactam (CAZ-AVI) as compared to meropenem for nosocomial pneumonia was established in a randomized, phase-III, non-inferiority trial REPROVE, which included Indian patients. We determined if the results for the Indian patients were in-line with the results of overall population. Descriptive analysis of efficacy and safety demonstrated ceftazidime-avibactam was comparable to meropenem in the management of nosocomial pneumonia in Indian patients and it may be a useful addition to the armamentarium of antibiotics for management of such infections with Enterobacterales and Pseudomonas., Competing Interests: Declaration competing of interest Dr P. Sathe was an investigator in the REPROVE study and received compensation for the same. Dr S. Kamat and Dr C. Adhav are full-time employees of Pfizer India Ltd. At the time of submission. None of the authors intend to unduly influence or promote any product through this publication., (Copyright © 2021 The Authors. Published by Elsevier B.V. All rights reserved.)