Early shift to oral antibiotic treatment for pyogenic vertebral osteomyelitis (SAVE): study protocol for an open label, non-inferiority, nation-wide randomized controlled clinical trial.

ABSTRACT:

Background

The current Danish National Guideline (DNG) for treatment of pyogenic vertebral osteomyelitis (PVO) recommends 6 weeks antibiotic (AB) treatment, with a 2-week intravenous (IV) AB lead-in followed by 4 weeks oral AB for uncomplicated PVO, and 12 weeks AB treatment with a 4-week IV AB lead-in followed by 8 weeks oral AB for complicated PVO. The primary objective of the current study is to investigate whether shortening the duration of IV AB to one week is non-inferior to the current DNG.

Methodology

The SAVE trial is an investigator initiated, randomized (1:1), controlled, non-inferiority, parallel group, open-label trial. Patients will be included at departments of infectious diseases in Denmark. All adult patients diagnosed with and treated for PVO will be assess

SUBMITTER: Theilgaard ZP 

PROVIDER: S-EPMC12802117 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature