Reviewed by Erica Stohs, MD, MPH, University of Nebraska
This multicentered randomized controlled trial evaluated an opt-out protocol to decrease unnecessary antibiotic use prescribed for non-ICU hospitalized patients with suspected sepsis.
Stewarding antibiotics has been challenging in the era of SEP-1 (sepsis management bundle regulation required by CMS), which did not incorporate the balancing measure of antibiotic overuse and its consequences. This RCT studied an opt-out intervention in which clinicians had to actively engage to continue antibiotics for carefully selected patients in whom broad spectrum agents were initiated due to suspected sepsis. Suspected sepsis was defined as having no positive blood cultures at 48-96 hours and active orders for broad spectrum antibiotics.
The study was directed at non critically ill adults on broad spectrum agents with negative blood cultures in ten hospitals between September 2018 to May 2020. Through detailed expert panel review and rigorous protocol development, investigators developed a 23-item safety checklist to determine if patients were eligible for the de-escalation opt-out protocol. For example, patients with ongoing signs and symptoms of infection (fever, leukocytosis, pneumonia, or related complications), concerning or incomplete microbiologic data, antibiotic pre-treatment, and immunocompromised status were excluded. If clinicians opted out (i.e., continued antibiotics), they discussed their rationale and future plan to de-escalate. In essence, this involved thorough audit and feedback. Primary outcome was post-enrollment days of therapy (DOT) up to 30 days. Secondary outcomes: 30-day safety events, including C diff infection, readmission, ICU admission, death, relapse of suspected sepsis.
Of the nearly 10 thousand patients screened, only 767 (8%) were enrolled. Intervened patients had 32% lower odds of antibiotic continuation and were exposed to fewer days of extended spectrum antibiotics (36% vs 44%). For patients in whom antibiotics were continued, DOT was similar. No safety issues were noted. Interestingly, despite a quite conservative safety checklist limiting eligibility, safety concerns were commonly cited by clinicians as reason to continue antibiotics. Addressing diagnostic uncertainty remains a challenge to expansion of an opt-out approach to antibiotic de-escalation in suspected sepsis.
Reference: Moehring RW, et al. Clinical Infectious Diseases 2023;76(3):433–442. DOI: 10.1093/cid/ciac787