About the project
‘Spondylodiscitis’ is a rare inflammation of the intervertebral discs and the adjacent vertebral bodies of the spine. The condition can be severe or even fatal, and occurs mainly in older people with multiple pre-existing conditions. It is usually treated with antibiotics over a total of six weeks. In most cases, patients initially receive the antibiotics as an intravenous drip for two weeks, followed by oral tablets. However, it is not yet clear exactly how long this intravenous treatment is actually necessary. Recent studies suggest that switching to tablets earlier could be just as safe and effective. The SWITCH-VO study is therefore investigating whether switching from intravenous antibiotic therapy to tablets after just 7 days is just as effective and safe as the standard practice of switching after 14 days.
Key points at a glance
The aim of the SWITCH-VO study is to determine whether switching earlier from intravenous (infusion) antibiotic treatment to treatment with tablets after 7 days is just as effective and safe as the standard practice of switching after 14 days.
To assess this, participants will be monitored for up to 24 weeks after the end of treatment. The study will investigate whether any of the following events occur: death, an unplanned operation on the spine, a recurrence of the spinal infection, a recurrence of bacterial spread in the blood, or the need to resume intravenous antibiotic treatment for a longer period in order to control the infection.
In addition, the two treatment groups will be compared in other respects. These include:
- how frequently the individual events mentioned occur
- the quality of life and personal well-being of patients, assessed using questionnaires
- patients’ experiences of the treatment, also based on questionnaires
- the length of hospital stay and whether a further hospital admission is required
- physical fitness, ability to cope with daily life and ability to work
- complications that may arise from intravenous treatment (for example, inflammation or problems with the venous access site)
- the occurrence of diarrhoea caused by the bacterium Clostridium difficile, which is often triggered by antibiotic treatment
- possible reasons why the treatment did not achieve the desired outcome
- how well the treatment is tolerated and how satisfied patients are with the treatment
- Employment status before, during and after treatment
With an incidence of 11 per 100,000 inhabitants, spondylodiscitis is a rare condition. Only through collaboration between numerous university hospitals, such as within the NUM, can the required size of the study cohort be achieved at all.
(Incidence: the number of new cases occurring within a population of a specific size)
The SWITCH-VO study is being conducted across 13 university hospitals. All participating patients will receive a course of antibiotics selected individually by a doctor specialising in infectious diseases. This selection takes into account the type of infection, the bacteria responsible, and personal factors. Within the first 7 days of starting intravenous antibiotic treatment, participants are randomly assigned to one of two treatment groups. This process is known as randomisation and ensures that the two groups are as comparable as possible. One group switches from intravenous treatment to antibiotics in tablet form after 7 days. The other group switches after 14 days. Once the course of antibiotic treatment has finished, all participants are monitored for a further 24 weeks. An independent group of doctors will then assess the success of the treatment. This group does not know which treatment group the patients belonged to, so that the assessment is as objective as possible. A total of 280 patients are to be enrolled in the study within 18 months.
Sponsor: University of Cologne
Project management: Regensburg University Hospital, Cologne University Hospital
Statistics: University Hospital Schleswig-Holstein
CRO: ZKS Cologne
PREM development: Bonn University Hospital
Patient representation: Cologne Patient Information Centre
Data management: NUKLEUS CDM Göttingen