CELL INTELLIGENCE · 肿瘤细胞治疗研究

Inclusion Criteria:

1. Age ≥18 years
2. 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)
3. The physician responsible for the patient decides to treat the patient for PVO
4. At time of randomization CRP has decreased to \< 75% of peak value or to \< 20 mg/l
5. At the time of randomization patient has received maximum 7 days of appropriate IV AB for PVO -

Exclusion Criteria:

1. Previous episodes of PVO within the past 24 months
2. Spinal implants inserted prior to current episode of PVO
3. Hypersensitivity to an AB intended for use in the patient and no alternative drugs available.
4. Oral ABs not possible due to suspicion of reduced absorption
5. Oral Abs not possible due to verified or expected bacterial susceptibility or due to expected toxicity of available regimen
6. Identification of fungus, mold, TB, Brucella, Actinomyces, Nocardia and P. aeruginosa as etiology
7. 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
8. Verified or expected reduced compliance (for example iv drug use)
9. Pregnancy
10. Breastfeeding
11. Women of childbearing potential, who at the time of inclusion are not using and/or who will not use an effective anticonception method during the treatment period.
12. Patients not capable of providing informed consent at time of screening for inclusion
13. Diagnosed or suspected concomitant or unrelated infections necessitating IV AB therapy beyond 7 days of duration at the time of randomization -

主要终点：Primary outcome · All-cause mortality · Six months after completion of oral antibiotic treatment；Primary outcome · Unplanned surgical intervention in relation to the spine · Six months after completion of oral antibiotic treatment；Primary outcome · Relapse of bacteremia with primary pathogen · Six months after completion of oral antibiotic treatment；Primary outcome · Relapse of bacteria with the initial pathogen being cultured from relevant material from infected areas in relation to the spine or iliopsoas muscle (detected by culture) · Six months after completion of oral antibiotic treatment；Primary outcome · Renewed course of intravenous antibiotic given for more than 7 days for treatment of pyogenic vertebral osteomyelitis · Six months after completion of oral antibiotic treatment
次要终点：Secondary outcome 1；Secondary outcome 2；Secondary outcome 3；Secondary outcome 4；Secondary outcome 5；Secondary outcome 6；Secondary outcome 7；Secondary outcome 8

• 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.

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.