Osteomyelitis; VertebraSAVENCT06250023
SAVE- Oral Antibiotics for Treatment of Vertebral Osteomyelitis
An observational study of Osteomyelitis; Vertebra, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteomyelitis; Vertebra
- What is being tested?
- Early shift til oral antibiotic treatment for osteomyelitis
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 530 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2024to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will be a nationwide, multicenter, investigator initiated, randomized, controlled, parallel group, open label, non-inferiority trial. The study will be conducted at departments of infectious diseases in Denmark and in collaboration with spinal surgery units carrying out infection-related spinal surgery. All patients diagnosed with PVO will be assessed for eligibility. Patients will be eligible for inclusion if they fulfill all the inclusion and none of the exclusion criteria.
Who may be able to join
- 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 -
Who cannot join
- 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
Show all 13Show fewer
- 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 -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Department of Infectious Diseases, Rigshospitalet, Copenhagen, Denmark
Copenhagen, 2100
Anne-Mette C Lebech, MD, +4535458622, anne-mette.lebech@regionh.dk
About this study
Official title: Early Shift to Oral Antibiotic Treatment for Pyogenic Vertebral Osteomyelitis (SAVE) - a Open Label Non-inferiority Nation-wide Study
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
- Being tested
- Early shift til oral antibiotic treatment for osteomyelitis
- Medical subject headings
- Osteomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early shift til oral antibiotic treatment for osteomyelitisOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. Receives: Other: Early shift til oral antibiotic treatment for osteomyelitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome
All-cause mortality
Measured: Six months after completion of oral antibiotic treatment
Primary outcome
Unplanned surgical intervention in relation to the spine
Measured: Six months after completion of oral antibiotic treatment
Primary outcome
Relapse of bacteremia with primary pathogen
Measured: Six months after completion of oral antibiotic treatment
Primary outcome
Relapse of bacteria with the initial pathogen being cultured from relevant material from infected areas in relation to the spine or iliopsoas muscle (detected by culture)
Measured: Six months after completion of oral antibiotic treatment
Primary outcome
Renewed course of intravenous antibiotic given for more than 7 days for treatment of pyogenic vertebral osteomyelitis
Measured: Six months after completion of oral antibiotic treatment
Secondary outcomes (13)
Secondary outcome 1
Occurrence of each component of the composite primary endpoint from the time of shift to oral AB treatment to six months after completion of oral AB treatment.
Measured: Six months after completion of oral antibiotic treatment
Secondary outcome 2
Median duration of hospital admission(s) from the time of shift to oral AB treatment to six months after completion of oral AB treatment (Admission defined as overnight stay at the department)
Measured: Six months after completion of oral antibiotic treatment
Secondary outcome 3
Number of readmissions from the time of shift to oral AB treatment to six months after completion of oral AB treatment
Measured: Six months after completion of oral antibiotic treatment
Secondary outcome 4
Proportion of patients receiving additional oral AB therapy beyond the duration defined in the protocol
Measured: Six months after completion of oral antibiotic treatment
Secondary outcome 5
Proportion of patients having early termination of allocated treatment strategy due to adverse events, patient preference, or any other reason
Measured: Six months after completion of oral antibiotic treatment
Secondary outcome 6
Proportion of patients experiencing complications associated with IV treatment (e.g., catheter infections, phlebitis, bleeding, venous thrombosis, need for replacement of catheter) from the time of initiation of IV treatment for PVO to six months after completion of oral AB treatment
Measured: Six months after completion of oral antibiotic treatment
Secondary outcome 7
Proportion of patients experiencing severe adverse events from ABs from the time of initiation of IV treatment for PVO to six months after completion of oral AB treatment
Measured: Six months after completion of oral antibiotic treatment
Secondary outcome 8
Proportion of patients experiencing adverse events from ABs from the time of initiation of IV treatment for PVO to six months after completion of oral AB treatment
Measured: Six months after completion of oral antibiotic treatment
Secondary outcome 9
Proportion of patients diagnosed with Clostridioides difficile associated diarrhea from the time of initiation of IV treatment for PVO to six months after completion of oral AB treatment
Measured: Six months after completion of oral antibiotic treatment
Secondary outcome 10
Quality of life scores (EQ-5D) at the following timepoints: Randomization, 1 week after the end of AB therapy, 1 month after the end of AB therapy, 6 months after the end of oral AB therapy, and 12 months after the end of oral AB therapy
Measured: Six months after completion of oral antibiotic treatment
Secondary outcome 11
Resource allocation/cost assessment determined by a combination of EQ5D, DALYs, Days of hospital admission and antibiotic prescribing costs
Measured: Six months after completion of oral antibiotic treatment
Secondary outcome 12
CRP, WBC, alkaline phosphatase and procalcitonin at randomization as well as CRP, WBC, alkaline phosphatase weekly during treatment and at week 4, 12 and 24 after completion of oral AB treatment.
Measured: Six months after completion of oral antibiotic treatment
Secondary outcome 13
Presence of microbial cell-free DNA in blood samples at the time of randomization and 6 months after the end of oral AB therapy
Measured: Six months after completion of oral antibiotic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start1 Feb 2024
- Primary completionApr 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteomyelitis; VertebraStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 530 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne-Mette Lebech, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250023
- Sponsor's protocol ID
- 2023-507617-96-01
- Other IDs
- 2023
- Acronym
- SAVE
- Status last verified
- Mar 2024
- First submitted
- 29 Nov 2023
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Shift to Oral Antibiotic Treatment for Pyogenic Vertebral Osteomyelitis (SAVE) - a Open Label Non-inferiority Nation-wide Study
- ClinicalTrials.gov ID
- NCT06250023
- Acronym / sponsor ID
- SAVE / 2023-507617-96-01
- Conditions
- Osteomyelitis; Vertebra
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 530 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| Early shift | – | Other: Early shift til oral antibiotic treatment for osteomyelitisEarly 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be a nationwide, multicenter, investigator initiated, randomized, controlled, parallel group, open label, non-inferiority trial. The study will be conducted at departments of infectious diseases in Denmark and in collaboration with spinal surgery units carrying out infection-related spinal surgery. All patients diagnosed with PVO will be assessed for eligibility. Patients will be eligible for inclusion if they fulfill all the inclusion and none of the exclusion criteria.
Key inclusion criteria (5 listed)
- 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 -
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early shift til oral antibiotic treatment for osteomyelitisTo 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. | Other | Early shift |
Primary outcome
Primary outcome
Time frame: Six months after completion of oral antibiotic treatment
All-cause mortality
Primary outcome
Time frame: Six months after completion of oral antibiotic treatment
Unplanned surgical intervention in relation to the spine
Primary outcome
Time frame: Six months after completion of oral antibiotic treatment
Relapse of bacteremia with primary pathogen
Primary outcome
Time frame: Six months after completion of oral antibiotic treatment
Relapse of bacteria with the initial pathogen being cultured from relevant material from infected areas in relation to the spine or iliopsoas muscle (detected by culture)
Primary outcome
Time frame: Six months after completion of oral antibiotic treatment
Renewed course of intravenous antibiotic given for more than 7 days for treatment of pyogenic vertebral osteomyelitis
13 secondary outcomes
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
Secondary outcome 13
Time frame: Six months after completion of oral antibiotic treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteomyelitis; Vertebra, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne-Mette Lebech, MD (+4535458622, anne-mette.lebech@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome (time frame: Six months after completion of oral antibiotic treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024; AzTrials last refreshed its copy on 8 Nov 2026.