SAVE- oral antibiotics for treatment of vertebral osteomyelitis
- Conditions
- Pyogenic vertebral osteomyelitisTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- CTIS2023-507617-96-01
- Lead Sponsor
- Rigshospitalet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 530
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
Previous episodes of PVO within the past 24 months, Verified or expected reduced compliance (for example iv drug use), Pregnancy, Diagnosed or suspected concomitant or unrelated infections necessitating IV AB therapy beyond 7 days of duration at the time of randomization, Breastfeeding, Patients not capable of providing informed consent at time of screening for inclusion, Spinal implants inserted prior to current episode of PVO, Hypersensitivity to an AB intended for use in the patient and no alternative drugs available., Oral ABs not possible due to suspicion of reduced absorption, Oral Abs not possible due to verified or expected bacterial susceptibility or due to expected toxicity of available regimen, Identification of fungus, mold, TB, Brucella, Actinomyces, Nocardia and P. aeruginosa as etiology, Severe immunocompromise defined as primary immunodeficiencies, uncontrolled HIV/AIDS, organ transplant recipients, hematological malignancies, patients undergoing biological therapy or chemotherapy and patients treated with prednisolone >=20 mg daily >14 days
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method