SAVE- Oral Antibiotics for Treatment of Vertebral Osteomyelitis (NCT06250023) | Clinical Trial Compass
RecruitingNot Applicable
SAVE- Oral Antibiotics for Treatment of Vertebral Osteomyelitis
Denmark530 participantsStarted 2024-02-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary outcome
Timeframe: Six months after completion of oral antibiotic treatment
2
Primary outcome
Timeframe: Six months after completion of oral antibiotic treatment
3
Primary outcome
Timeframe: Six months after completion of oral antibiotic treatment
4
Primary outcome
Timeframe: Six months after completion of oral antibiotic treatment
5
Primary outcome
Timeframe: Six months after completion of oral antibiotic treatment
. 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)