Clinical question: What is the safety and efficacy of switching from IV to oral antibiotic therapy after three to five days in patients with gram-negative bacteremia?
Background: Bacteremia is ubiquitous among hospitalized patients and is traditionally treated with prolonged courses of IV antibiotic therapy after clearance of blood cultures. To date, there has been limited, low-quality evidence demonstrating the safety of transitioning to oral therapy to complete the course of therapy recommended for gram-negative bacteremia.
Study design: Randomized, controlled, open-label, noninferiority study.
Setting: 11 sites in Bahrain, Kuwait, Qatar, and Türkiye
Synopsis: A total of 1,476 patients with monomicrobial Enterobacterales bacteremia admitted to the hospital were assessed for inclusion in the trial. Only 174 patients were randomized due to many patients not meeting eligibility requirements, including hemodynamic stability with resolution of fever >48 hours and source control. Randomized patients received either IV or oral antibiotics, after three to five days of IV therapy (85 to the IV group, 89 to the oral group). The primary endpoint was treatment failure within 90 days including death, need for additional antimicrobial therapy, microbiological relapse, or infection-related readmission. Treatment failure was documented in 25.6% of the IV group and 21.7% of the oral group. Median length of stay was three days shorter in the oral group; six days versus nine days.
These findings were limited in application for complicated infections: the study excluded neutropenic patients, central nervous system infections, and infective endocarditis. Additionally, resistance profiles excluded 23% of possible enrollment due to no oral therapy being available.
Bottom line: Switching clinically stable patients with gram-negative bacteremia from IV to oral antibiotic therapy was non-inferior to completing a course of therapy with IV alone and may reduce hospital length of stay.
Citation: Omrani AS, et al. Switch to oral antibiotics in gram-negative bacteraemia: a randomized, open-label, clinical trial. Clin Microbiol Infect. 2024;30(4):492-8. doi: 10.1016/j.cmi.2023.10.014.
Dr. Dreer is an academic hospitalist in the section of hospital medicine at UPMC Presbyterian Hospital, and a clinical assistant professor of medicine at the University of Pittsburgh School of Medicine, both in Pittsburgh.