NCT06250023

SAVE- Oral Antibiotics for Treatment of Vertebral Osteomyelitis

Early Shift to Oral Antibiotic Treatment for Pyogenic Vertebral Osteomyelitis (SAVE) - a Open Label Non-inferiority Nation-wide Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 530 (estimated)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Background The current Danish National Guideline 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 2-4-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 for both complicated and uncomplicated PVO is non-inferior to the current Danish National Guideline.

Conditions

• Osteomyelitis; Vertebra

Interventions

Type	Name	Description
OTHER	Early shift til oral antibiotic treatment for osteomyelitis	To investigate whether early transition to oral AB treatment after one week of IV treatment is non-inferior to the current national guideline of continued IV AB treatment for two to four weeks followed by oral AB treatment for PVO.

Timeline

• Start date: 2024-02-01
• Primary completion: 2026-04-01
• Completion: 2026-10-01
• First posted: 2024-02-08
• Last updated: 2024-03-22

Locations

1 site across 1 country: Denmark