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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years

• Diagnosed with PVO by a physician based on clinical symptoms and findings consistent with PVO in combination with diagnostic imaging (MRI, PET/CT or PET/MRI)

• The physician responsible for the patient decides to treat the patient for PVO

• At time of randomization CRP has decreased to \< 75% of peak value or to \< 20 mg/l

• At the time of randomization patient has received maximum 7 days of appropriate IV AB for PVO -

Locations
Other Locations
Denmark
Department of Infectious Diseases, Rigshospitalet, Copenhagen, Denmark
RECRUITING
Copenhagen
Contact Information
Primary
Anne-Mette Lebech, MD
anne-mette.lebech@regionh.dk
+4535458622
Time Frame
Start Date: 2024-02-01
Estimated Completion Date: 2026-10
Participants
Target number of participants: 530
Treatments
Standart of care
Standard of care (comparator)~* Uncomplicated PVO: 2 weeks IV ABs followed by oral ABs for 4 weeks.~* Complicated PVO: 2-4 weeks IV ABs followed by oral ABs for 8 weeks.
Early shift
Early shift to oral ABs (intervention)~* Uncomplicated PVO: 1 week IV ABs followed by 5 weeks of oral ABs.~* Complicated PVO: 1 week IV ABs followed by 11 weeks of oral ABs.
Related Therapeutic Areas
Sponsors
Leads: Rigshospitalet, Denmark

This content was sourced from clinicaltrials.gov

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