Actively Recruiting
SAVE- Oral Antibiotics for Treatment of Vertebral Osteomyelitis
Led by Rigshospitalet, Denmark · Updated on 2024-03-22
530
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
SAVE- Oral Antibiotics for Treatment of Vertebral Osteomyelitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with pyogenic vertebral osteomyelitis by a physician based on clinical symptoms and diagnostic imaging (MRI, PET/CT, or PET/MRI)
- Physician has decided to treat the patient for PVO
- At randomization, C-reactive protein (CRP) has decreased to less than 75% of peak value or below 20 mg/l
- Patient has received a maximum of 7 days of appropriate intravenous antibiotic treatment for PVO at time of randomization
You will not qualify if you...
- Previous episodes of pyogenic vertebral osteomyelitis within the past 24 months
- Presence of spinal implants inserted before the current PVO episode
- Hypersensitivity to intended antibiotics with no alternatives available
- Oral antibiotics not possible due to suspected reduced absorption
- Oral antibiotics not possible due to bacterial resistance or expected toxicity
- Infection caused by fungus, mold, tuberculosis, Brucella, Actinomyces, Nocardia, or Pseudomonas aeruginosa
- Severe immunocompromise including primary immunodeficiencies, uncontrolled HIV/AIDS, organ transplant, hematological cancers, biological therapy or chemotherapy, or prednisolone 20 mg daily or more for over 14 days
- Verified or expected reduced treatment compliance (e.g., intravenous drug use)
- Pregnancy
- Breastfeeding
- Women of childbearing potential not using effective contraception during treatment
- Inability to provide informed consent at screening
- Concomitant or unrelated infections requiring intravenous antibiotics beyond 7 days at randomization
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Department of Infectious Diseases, Rigshospitalet, Copenhagen, Denmark
Copenhagen, Denmark, 2100
Actively Recruiting
Research Team
A
Anne-Mette Lebech, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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