Early shift to oral antibiotic treatment of pyogenic vertebral osteomyelitis – a open label non-inferiority randomized nationwide study.

Pyogenic vertebral osteomyelitis

A composite of the following occurring from the time of shift to oral AB treatment to six months after completion of oral AB treatment: •All-cause mortality •Unplanned surgical intervention in relation to the spine •Relapse of bacteremia with the primary pathogen •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) •Renewed course of IV ABs given for >7 days for PVO

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., 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), Number of readmissions from the time of shift to oral AB treatment to six months after completion of oral AB treatment, Proportion of patients receiving additional oral AB therapy beyond the duration defined in the protocol, Proportion of patients having early termination of allocated treatment strategy due to adverse events, patient preference, or any other reason, 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, 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, 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, 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, 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, Resource allocation/cost assessment determined by a combination of EQ5D, DALYs, Days of hospital admission and antibiotic prescribing costs, 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., Presence of microbial cell-free DNA in blood samples at the time of randomization and 6 months after the end of oral AB therapy

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