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 Type
OBSERVATIONAL
Enrollment
530
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.
Department of Infectious Diseases, Rigshospitalet, Copenhagen, Denmark
Copenhagen, Denmark
RECRUITINGPrimary 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
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