SAVE- Oral Antibiotics for Treatment of Vertebral Osteomyelitis (NCT06250023) | Clinical Trial Compass
RecruitingNot Applicable
SAVE- Oral Antibiotics for Treatment of Vertebral Osteomyelitis
Denmark530 participantsStarted 2024-02-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 -
Exclusion criteria
✕. Previous episodes of PVO within the past 24 months
✕. 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
What they're measuring
1
Primary outcome
Timeframe: Six months after completion of oral antibiotic treatment
2
Primary outcome
Timeframe: Six months after completion of oral antibiotic treatment
3
Primary outcome
Timeframe: Six months after completion of oral antibiotic treatment
4
Primary outcome
Timeframe: Six months after completion of oral antibiotic treatment
5
Primary outcome
Timeframe: Six months after completion of oral antibiotic treatment