BridgeMD
SAVE- oral antibiotics for treatment of vertebral osteomyelitis
EU CTIS ID: 2023-507617-96-01
What this study is testing
To investigate whether early transition to oral antibiotic (AB) treatment after one week of intravenous (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 pyogenic vertebral osteomyelitis (PVO).
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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) or perioperatively identified
- 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
You likely can't join if
- Previous episodes of PVO within the past 24 months
- 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 and/or Nocardia as etiology
- Severe immunocompromise defined as transplant recipients, patients having hematological malignancies currently undergoing or having undergone active medical treatment within the last six months, patients having solid organ cancers currently undergoing immunosuppressive treatment, or at current risk of febrile neutropenia and patients having received an IL6 inhibitor within the last 3 months
- 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.
- A positive blood-culture taken 48-72 hours after initiation of appropriate therapy for PVO in patients having S. aureus bacteremia
See the full eligibility 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) or perioperatively identified
- 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
- Previous episodes of PVO within the past 24 months
- 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 and/or Nocardia as etiology
- Severe immunocompromise defined as transplant recipients, patients having hematological malignancies currently undergoing or having undergone active medical treatment within the last six months, patients having solid organ cancers currently undergoing immunosuppressive treatment, or at current risk of febrile neutropenia and patients having received an IL6 inhibitor within the last 3 months
- 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.
- A positive blood-culture taken 48-72 hours after initiation of appropriate therapy for PVO in patients having S. aureus bacteremia
- Verified or expected reduced compliance (for example iv drug use)
- Pregnancy
- Diagnosed or suspected concomitant or unrelated infections necessitating IV AB therapy beyond 7 days of duration at the time of randomization
- Breastfeeding
- Patients not capable of providing informed consent at time of screening for inclusion
- Spinal implants inserted prior to current episode of PVO with P. aeroginosa identified as etiology for current 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.