Stop, Don’t Start: How Do We Improve Clinical Trial Design Integrating Molecular Diagnostics and Antimicrobial Stewardship?

To the Editor—We appreciate the well-reasoned insights provided by Hu et al and largely agree with their conclusions. However, we wish to clarify one point. Hu et al comment on the need for studies pairing rapid molecular diagnostics with antimicrobial stewardship practices rather than studies that rely on diagnostics alone. Our trial did just that. We integrated direct-from-blood testing results into a robust, preexisting [1–3] antimicrobial stewardship system. This included communication of results via text pages, inclusion of antibiotic stewardship recommendations with results, pop-up notifications for patients with ongoing vancomycin and negative direct-from-blood results for Staphylococcus aureus, incorporation of direct-from-blood testing results into daily stewardship notes by a dedicated antimicrobial stewardship team, and engagement of Vanderbilt University Medical Center Antimicrobial Stewardship Program members with providers [4, 5]. Except for specific actions in response to direct-from-blood testing results, these stewardship activities occurred in both the intervention and control groups. Integration of rapid results into robust diagnostic stewardship approaches did not impact the primary and secondary outcomes. Whether the direct-from-blood testing would have performed differently in a context without these structured antimicrobial stewardship systems is unknown.