SAVE- Oral Antibiotics for Treatment of Vertebral Osteomyelitis

Last updated: March 20, 2024
Sponsor: Rigshospitalet, Denmark
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteomyelitis

Treatment

Early shift til oral antibiotic treatment for osteomyelitis

Clinical Study ID

NCT06250023
2023-507617-96-01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥18 years
  2. Diagnosed with PVO by a physician based on clinical symptoms and findings consistentwith 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 ABfor PVO -

Exclusion

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 drugsavailable.
  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 toexpected toxicity of available regimen
  6. Identification of fungus, mold, TB, Brucella, Actinomyces, Nocardia and P. aeruginosaas etiology
  7. Severe immunocompromise defined as primary immunodeficiencies, uncontrolled HIV/AIDS,organ transplant recipients, hematological malignancies, patients undergoingbiological therapy or chemotherapy and patients treated with prednisolone >=20 mgdaily >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 whowill 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 therapybeyond 7 days of duration at the time of randomization -

Study Design

Total Participants: 530
Treatment Group(s): 1
Primary Treatment: Early shift til oral antibiotic treatment for osteomyelitis
Phase:
Study Start date:
February 01, 2024
Estimated Completion Date:
October 31, 2026

Connect with a study center

  • Department of Infectious Diseases, Rigshospitalet, Copenhagen, Denmark

    Copenhagen, 2100
    Denmark

    Active - Recruiting

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