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Study on Early Oral Antibiotic Treatment for Vertebral Osteomyelitis Using Cefuroxime, Dicloxacillin, and Ceftriaxone for Adult Patients

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of pyogenic vertebral osteomyelitis, a type of bone infection that affects the spine. The study will explore the effectiveness of switching from intravenous (IV) antibiotics to oral antibiotics after one week of IV treatment. The antibiotics being studied include cefuroxime, dicloxacillin, ceftriaxone, amoxicillin, clavulanic acid, cloxacillin, flucloxacillin, ciprofloxacin, clindamycin, vancomycin, linezolid, moxifloxacin, benzylpenicillin, ampicillin, rifampicin, phenoxymethylpenicillin, sulfamethoxazole, trimethoprim, tolu balsam, and meropenem. Some patients will receive a placebo as part of the study.

The purpose of the study is to determine if an early switch to oral antibiotics is as effective as the current standard treatment, which involves two to four weeks of IV antibiotics followed by oral antibiotics. Participants will initially receive IV antibiotics for one week. After this period, they will be randomly assigned to either continue with IV antibiotics or switch to oral antibiotics. The study will monitor the participants for any complications or relapses of the infection over a period of six months after completing the antibiotic treatment.

Throughout the study, various health indicators will be assessed, including the occurrence of any adverse events, the need for additional treatments, and the overall quality of life of the participants. The study aims to provide valuable insights into the potential benefits of transitioning to oral antibiotics earlier in the treatment process for pyogenic vertebral osteomyelitis.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    Upon joining the study, the treatment begins with an intravenous (IV) administration of antibiotics for a duration of one week. This phase is crucial for managing the infection effectively.

    The antibiotics used during this phase may include cefuroxime, dicloxacillin, ceftriaxone, among others. The specific medication and dosage will be determined based on individual medical needs.

  2. Step 2

    Transition to oral antibiotics

    After completing one week of IV antibiotic treatment, there is a transition to oral antibiotics. This shift is part of the study's objective to evaluate the effectiveness of early oral treatment.

    The oral antibiotics may include amoxicillin, clindamycin, linezolid, and others. The duration and dosage will be tailored to the patient's condition and response to treatment.

  3. Step 3

    Monitoring and follow-up

    Throughout the treatment, regular monitoring of health indicators such as CRP (C-reactive protein) levels, white blood cell count, and other relevant markers will be conducted to assess the response to treatment.

    Follow-up assessments will occur at various intervals: one week, one month, six months, and twelve months after the completion of oral antibiotic therapy. These assessments will help evaluate the long-term effectiveness and safety of the treatment.

  4. Step 4

    Completion of treatment

    The treatment concludes after the prescribed course of oral antibiotics is completed. The total duration of the study participation, including follow-up, extends up to six months after the end of oral antibiotic therapy.

    During this period, any adverse events or complications will be documented to ensure patient safety and to gather comprehensive data on the treatment's impact.

Who can join the trial?

5 criteria

  • Must be 18 years or older.
  • Must have been diagnosed with pyogenic vertebral osteomyelitis (PVO) by a doctor. This means the doctor has found signs and symptoms of this condition and confirmed it with special imaging tests like MRI, PET/CT, or PET/MRI.
  • The doctor in charge has decided to treat the patient for PVO.
  • At the time of joining the study, the patient's CRP level (a blood test that shows inflammation) must have decreased to less than 75% of its highest value or be less than 20 mg/l.
  • At the time of joining the study, the patient must have received no more than 7 days of intravenous (IV) antibiotic treatment for PVO.

Who cannot join the trial?

3 criteria

  • Patients who are not diagnosed with pyogenic vertebral osteomyelitis. This is an infection in the bones of the spine.
  • Patients who are younger than 18 years old or older than 65 years old.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Intravenous Antibiotics

    are used initially in the treatment of pyogenic vertebral osteomyelitis. These medications are administered directly into the bloodstream through a vein, allowing for rapid and effective treatment of the infection. The trial investigates whether starting with one week of intravenous antibiotics is sufficient before switching to oral antibiotics.

  • Oral Antibiotics

    are medications taken by mouth to treat infections. In this trial, the focus is on transitioning to oral antibiotics after an initial period of intravenous treatment. The study aims to determine if this early switch is as effective as the longer intravenous treatment followed by oral antibiotics, which is the current standard practice.

What is already known about the treatment

Amoxicillin – Amoxicillin is an antibiotic that is typically administered orally in the form of tablets or capsules. It is widely used in medicine and is well-documented in medical literature. The main therapeutic indication for amoxicillin is the treatment of bacterial infections, including pyogenic vertebral osteomyelitis. At the molecular level, amoxicillin works by inhibiting the synthesis of bacterial cell walls, leading to the destruction of the bacteria. It is classified pharmacologically as a penicillin-type antibiotic.

Investigated diseases

Pyogenic vertebral osteomyelitis – This is an infection of the vertebrae caused by bacteria, leading to inflammation and destruction of the bone. It typically begins with the spread of bacteria through the bloodstream to the spine, often originating from another infection site in the body. The disease can cause severe back pain, fever, and sometimes neurological symptoms if the infection affects the spinal cord or nerves. As the infection progresses, it can lead to the formation of abscesses and the destruction of the vertebral structure. This can result in spinal instability or deformity if not managed properly. The condition requires careful monitoring to prevent complications and ensure proper healing of the affected vertebrae.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507617-96-01Estimated enrolment374 patientsSponsorRegion Hovedstaden

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