SAVE- Oral Antibiotics for Treatment of Vertebral Osteomyelitis

Rigshospitalet

Status: Enrolling

Conditions: Osteomyelitis; Vertebra

Treatments: Other: Early shift til oral antibiotic treatment for osteomyelitis

Study type: Observational

Funder types: Other

Identifiers

NCT06250023

2023-507617-96-01

Details and patient eligibility

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.

Enrollment: 530 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 -

Trial design

530 participants in 2 patient groups

Standart of care

Description:

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

Description:

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.

Treatment:

Other: Early shift til oral antibiotic treatment for osteomyelitis