The article discusses the failure of inhaled colistimethate sodium to reduce exacerbations associated with Pseudomonas aeruginosa infection during the pandemic. The disparity in findings between two trials, PROMIS I and PROMIS II, highlights the impact of pandemic conditions on the effectiveness of the therapy. While PROMIS I showed significant benefits, PROMIS II, conducted during the pandemic, did not demonstrate the same advantages. The article delves into the differences in trial outcomes, the historical context of the therapy, and the challenges posed by the pandemic on clinical trials and data interpretation. It also touches on the potential implications for regulatory approval and the need for alternative pathways in light of existing standards of care.
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by Ted Bosworth at www.medscape.com 07-31-2023
https://www.medscape.com/viewarticle/994988Deeper Inquiries