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Recruiting NCT06250023

SAVE- Oral Antibiotics for Treatment of Vertebral Osteomyelitis

— Observational Osteomyelitis; Vertebra

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Early shift til oral antibiotic treatment for osteomyelitis.
Who it may be relevant to
Registry conditions: Osteomyelitis; Vertebra. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Early Shift to Oral Antibiotic Treatment for Pyogenic Vertebral Osteomyelitis (SAVE) - a Open Label Non-inferiority Nation-wide Study

Overview

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.

Interventions

  • Other 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.

Primary outcome measures

  • Primary outcome [Time frame: Six months after completion of oral antibiotic treatment]
  • Primary outcome [Time frame: Six months after completion of oral antibiotic treatment]
  • Primary outcome [Time frame: Six months after completion of oral antibiotic treatment]
  • Primary outcome [Time frame: Six months after completion of oral antibiotic treatment]
  • Primary outcome [Time frame: Six months after completion of oral antibiotic treatment]
Secondary outcome measures (12)
  • Secondary outcome 1 [Time frame: Six months after completion of oral antibiotic treatment]
  • Secondary outcome 2 [Time frame: Six months after completion of oral antibiotic treatment]
  • Secondary outcome 3 [Time frame: Six months after completion of oral antibiotic treatment]
  • Secondary outcome 4 [Time frame: Six months after completion of oral antibiotic treatment]
  • Secondary outcome 5 [Time frame: Six months after completion of oral antibiotic treatment]
  • Secondary outcome 6 [Time frame: Six months after completion of oral antibiotic treatment]
  • Secondary outcome 7 [Time frame: Six months after completion of oral antibiotic treatment]
  • Secondary outcome 8 [Time frame: Six months after completion of oral antibiotic treatment]
  • Secondary outcome 9 [Time frame: Six months after completion of oral antibiotic treatment]
  • Secondary outcome 10 [Time frame: Six months after completion of oral antibiotic treatment]
  • Secondary outcome 11 [Time frame: Six months after completion of oral antibiotic treatment]
  • Secondary outcome 12 [Time frame: Six months after completion of oral antibiotic treatment]

Eligibility criteria

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
  • Verified or expected reduced compliance (for example iv drug use)
  • Pregnancy
  • Breastfeeding
  • 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.
  • Patients not capable of providing informed consent at time of screening for inclusion
  • Diagnosed or suspected concomitant or unrelated infections necessitating IV AB therapy beyond 7 days of duration at the time of randomization -

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Denmark · 1 center
  • Department of Infectious Diseases, Rigshospitalet, Copenhagen, Denmark — Copenhagen

Identifiers

NCT: NCT06250023 · 2023-507617-96-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗