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SAVE- Oral Antibiotics for Treatment of Vertebral Osteomyelitis
Sponsor: Rigshospitalet, Denmark
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.
Official title: Early Shift to Oral Antibiotic Treatment for Pyogenic Vertebral Osteomyelitis (SAVE) - a Open Label Non-inferiority Nation-wide Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
530
Start Date
2024-02-01
Completion Date
2026-10
Last Updated
2024-03-22
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Department of Infectious Diseases, Rigshospitalet, Copenhagen, Denmark
Copenhagen, Denmark