An observational study in Osteomyelitis; Vertebra, sponsored by Rigshospitalet, Denmark. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-22.
Sponsored by Rigshospitalet, Denmark · Observational
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.
105 studies on the registry are indexed under Osteomyelitis; 30 are open to participants now.
This study's planned enrollment of 530 is above the median of 86 across 41 observational studies indexed under Osteomyelitis.
Browse Osteomyelitis studies →Rigshospitalet, Denmark is the lead sponsor of 1,007 studies on the registry; 175 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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.
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
All-cause mortality
Time frame: Six months after completion of oral antibiotic treatment
Primary outcome
Unplanned surgical intervention in relation to the spine
Time frame: Six months after completion of oral antibiotic treatment
Primary outcome
Relapse of bacteremia with primary pathogen
Time frame: 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)
Time frame: 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
Time frame: Six months after completion of oral antibiotic treatment
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.
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Six months after completion of oral antibiotic treatment
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2024 (actual). Primary completion is estimated for Apr 2026, 26 months after the start.
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