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Article History

Accepted: 3 December 2025

First Online: 23 January 2026

Declarations

:

: Sunil Panda, Shrinivas Chavan, Sumit Agarwal, Neha Sharma, Parth Bipinkumar, Harshal Chaudhari and Dipak Solanki were study investigators and received funding for the conduct of the study. Supriya Sonowal, Dipak Patil, Pravin Ghadge and Suyog Mehta are full-time employees of Sun Pharma Laboratories Limited. Mandodari Rajurkar, Sapan Behera and Lalit Lakhwani were full-time employees of Sun Pharma Laboratories Limited during the conduct of the study. Sadhna Joglekar was a full-time employee of Sun Pharmaceutical Industries Limited during the conduct of the study. She is currently employed by Novartis. The views expressed in the article are the author’s views and do not necessarily reflect the views or official position of Novartis.

: Two subgroup analyses of this study were presented at the 34th Congress of the European Society of Clinical Microbiology and Infectious Diseases, held in Barcelona, Spain, from 27 to 30 April, 2024.

: The study protocol was approved by institutional ethics committees at each study site prior to study initiation. All patients were required to provide mandatory written informed consent. Good Clinical Practice guidelines, local applicable regulations and the Declaration of Helsinki were followed. Furthermore, this study conformed to all regulations concerning the use of personal data.

: To receive the fixed-dose combination of cephalexin extended release and clavulanate potassium during the study, eligible patients were required to provide written informed consent. The patients were informed about the study treatment and the scope of the study, and informed consent was obtained from all participants before the screening procedure. An additional written informed consent was obtained from parents or legally acceptable representatives for patients aged < 18 years.

: Not applicable.

: The data substantiating the results of this phase IV study can be obtained from the corresponding author upon reasonable request.

: Not applicable.

: All authors made substantial contributions to the conception or design of the work, or the acquisition, analysis or interpretation of data. SP, SC, SA, NS, PB, HC and DS contributed to the study conduct and data acquisition. LL, SM and SJ were involved in designing the study. MR, SB, SS, DP and PG were involved in data interpretation. All authors were involved in revising the manuscript critically for important intellectual content, approved the final version to be published and agreed to be accountable for all aspects of the work.