
==== Front
Indian J Crit Care Med
Indian J Crit Care Med
IJCCM
Indian Journal of Critical Care Medicine : Peer-reviewed, Official Publication of Indian Society of Critical Care Medicine
0972-5229
1998-359X
Jaypee Brothers Medical Publishers

10.5005/jp-journals-10071-24699
Letter to the Editor
Author Response
Vijayakumar M 1https://orcid.org/0000-0001-6866-4709

Selvam Velmurugan 2https://orcid.org/0000-0002-9495-2293

Renuka MK 3https://orcid.org/0000-0002-7412-2989

Rajagopalan Ram E 4https://orcid.org/0000-0001-9486-3285

1–4 Department of Critical Care Medicine, Sri Ramachandra Institute of Higher Education and Research, Chennai, Tamil Nadu, India
Vijayakumar M, Department of Critical Care Medicine, Sri Ramachandra Institute of Higher Education and Research, Chennai, Tamil Nadu, India, Phone: +91 9642599067, e-mail: vijay092@gmail.com
5 2024
30 4 2024
28 5 512512
Copyright © 2024; The Author(s).
2024
https://creativecommons.org/licenses/by-nc/4.0/ © The Author(s). 2024 Open Access. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by-nc/4.0/), which permits unrestricted use, distribution, and non-commercial reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
How to cite this article: Vijayakumar M, Selvam V, Renuka MK, Rajagopalan RE. Author Response. Indian J Crit Care Med 2024;28(5):512.

Keywords

Antibacterial
Carbapenem-resistant enterobacterales
Critically ill adults
Observational study
Prospective study
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pmcWe express our gratitude to Riddhi Kundu and Sumit Roy Chowdhury for demonstrating a keen interest in our research.1 We value their invaluable insights. Our study findings concluded that the ceftazidime–avibactam with or without aztreonam (CAZ-AVI ± AZT) group exhibited a statistically significant clinical response compared to the polymyxin monotherapy for carbapenemase-producing gram-negative organisms. However, the study did not find any survival benefit, microbiological response, or side effects between the two groups.

We acknowledge the perceptive observation made by readers regarding higher baseline SOFA scores in the polymyxin group compared to the CAZ-AVI ± AZT group (6 vs 9; p = 0.09). This distinction could have potentially contributed to a more favorable clinical success outcome in the CAZ-AVI ± AZT group. It is essential to underscore the nature of our study as a prospective observational one, lacking randomization of baseline characteristics across comparative groups. Observational studies, particularly prospective cohorts, are susceptible to undetected confounding variables or omissions, potentially influencing study outcomes.2 The external validity or generalizability of prospective studies may be limited, as the characteristics of study participants may not fully represent the diversity observed in real-world clinical scenarios.

Nevertheless, our study revealed no statistically significant differences in SOFA scores among the study groups. The composite outcome was subjected to rigorous testing using the Cox multivariate regression model, accounting for baseline SOFA scores and prevailing comorbidities. Unlike univariate methods, the Cox model allows simultaneous assessment of multiple factors, enabling a comprehensive evaluation of their impact on survival time.3

We concur with the readers’ perspective on the necessity of a large-scale randomized controlled study. Our study, while providing valuable insights, has inherent limitations, and we welcome further investigations to strengthen the evidence base in this complex clinical context. We anticipate that forthcoming large prospective Indian studies on this topic will contribute valuable insights and further enrich the scientific understanding of these complex clinical scenarios.

Orcid

Vijayakumar M https://orcid.org/0000-0001-6866-4709

Velmurugan Selvam https://orcid.org/0000-0002-9495-2293

Renuka MK https://orcid.org/0000-0002-7412-2989

Ram E Rajagopalan https://orcid.org/0000-0001-9486-3285

Source of support: Nil

Conflict of interest: None
==== Refs
References

1. Kundu R Chowdhury SR Management of CRE infections: High time for an RCT? Indian J Crit Care Med 2024 28 5 511
2. Rochefort-Maranda G Inflated effect sizes and underpowered tests: How the severity measure of evidence is affected by the winner's curse Philosophical Studies 2021 178 133 145 10.1007/s11098-020-01424-z
3. Deo SV Deo V Sundaram V Survival analysis—part 2: Cox proportional hazards model Indian J Thorac Cardiovasc Surg 2021 37 2 229 233 10.1007/s12055-020-01108-7 33642726
