CHEST Guidelines-Response_chest

Response_chest_26 (2)

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The document is a byline and correspondence regarding a clinical study published by the American College of Chest Physicians in 2018. The study investigates the efficacy of a combination treatment with clarithromycin, naproxen, and oseltamivir for patients hospitalized with the influenza A(H3N2) infection. The study went through initial registration on January 25, 2015, with a primary outcome of nasopharyngeal aspirate (NPA) viral load reduction and several secondary outcomes, including fever resolution, hospitalization duration, and 1-month mortality rate.<br /><br />The researchers later amended the protocol on February 16, 2015, before any participants were enrolled. The primary outcome was changed to a 30-day mortality rate, and additional secondary outcomes were added including NPA viral load changes, pneumonia severity index changes, the percentage of influenza A (H3N2) neuraminidase inhibitor-resistant virus (NIRV) quasispecies post-treatment, length of hospitalization, and adverse events during treatment. These changes were intended to refine the study's focus and outcomes but were not initially updated in the trial registration, a discrepancy which was later rectified.<br /><br />Dr. Ivan F. N. Hung and Dr. Kwok-Yung Yuen, affiliated with The University of Hong Kong's Departments of Medicine and Microbiology, address the discrepancy with gratitude to Drs. Mazzetti and Neary for pointing it out. They assert that the amendments occurred prior to subject enrollment and emphasize that this did not involve inappropriate outcome switching or reclassification. The results demonstrated significant improvements in the treatment group’s 30-day mortality rates and secondary outcomes, and they urge that these amendments should not lead to misinterpretation or excessive implementation of the treatment based on these results.

Keywords

clinical study

American College of Chest Physicians

clarithromycin

naproxen

oseltamivir

influenza A(H3N2)

30-day mortality rate

protocol amendment

nasopharyngeal aspirate

neuraminidase inhibitor-resistant virus