SAVE- Oral Antibiotics for Treatment of Vertebral Osteomyelitis

NCT ID: NCT06250023

Last Updated: 2024-03-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 530 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2026-10-31

Brief 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.

Conditions

Osteomyelitis; Vertebra

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

Early shift til oral antibiotic treatment for osteomyelitis

Intervention Type: OTHER

To investigate whether early transition to oral AB treatment after one week of IV treatment is non-inferior to the current national guideline of continued IV AB treatment for two to four weeks followed by oral AB treatment for PVO.

Interventions

Early shift til oral antibiotic treatment for osteomyelitis

To investigate whether early transition to oral AB treatment after one week of IV treatment is non-inferior to the current national guideline of continued IV AB treatment for two to four weeks followed by oral AB treatment for PVO.

Intervention Type: OTHER

Eligibility Criteria

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 -

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Anne-Mette Lebech

Consultant, associate professor, MD Dsc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Infectious Diseases, Rigshospitalet, Copenhagen, Denmark

Copenhagen, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Anne-Mette Lebech, MD

Role: CONTACT

anne-mette.lebech@regionh.dk

+4535458622

Facility Contacts

Anne-Mette C Lebech, MD

Role: primary

anne-mette.lebech@regionh.dk

+4535458622

Other Identifiers

2023-507617-96-01

Identifier Type: -

Identifier Source: org_study_id