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SODIUM FUSIDATE

Clinical trials investigating SODIUM FUSIDATE are studying treatment for pyogenic vertebral osteomyelitis, a spinal bone infection. The main goal is to see whether an early switch to oral antibiotics is as effective as longer intravenous treatment. These trials focus on adults with this infection and measure death, surgery, relapse, and the need for more IV antibiotics.

Table of contents

Trial overview

The available trial for SODIUM FUSIDATE is titled “SAVE- oral antibiotics for treatment of vertebral osteomyelitis” and is listed as authorised.[1] It is an interventional study, which means researchers assign a treatment plan and then compare outcomes.[1]

This trial studies people with pyogenic vertebral osteomyelitis, a bacterial infection of the spine bones.[1] The study includes 530 participants and is in Phase 3.[1]

Study design and treatment plan

The main question is whether an early switch to oral antibiotic treatment after one week of intravenous (IV) treatment is non-inferior to the current national guideline approach.[1] Non-inferior means the new plan is not worse than the standard treatment by an important amount.[1]

The current guideline approach described in the trial is continued IV antibiotic treatment for 2 to 4 weeks, followed by oral treatment.[1] The trial compares this with an earlier move to oral antibiotics, and SODIUM FUSIDATE is one of the oral antibiotic options listed in the intervention set.[1]

The intervention list also includes several other antibiotics, which shows that the study is testing a treatment strategy rather than only one single medicine.[1]

Who may participate

The trial is focused on patients with pyogenic vertebral osteomyelitis.[1] The source data do not provide more detailed inclusion or exclusion rules, such as age limits or lab test requirements.[1]

Because the condition is an infection of the spine, the study is aimed at patients who need antibiotic treatment for this serious bone infection.[1]

What the trial measures

The primary outcome is a composite result, which means several important events are grouped together into one main measure.[1] The study tracks these events from the time of switch to oral antibiotic treatment until 6 months after oral treatment ends.[1]

  • All-cause mortality: whether any death occurs during the study period.[1]

  • Unplanned surgical intervention in relation to the spine: whether a spine operation is needed unexpectedly.[1]

  • Relapse of bacteremia with the primary pathogen: whether the bacteria return in the blood.[1]

  • Relapse of bacteria found again in material from infected areas near the spine or iliopsoas muscle, confirmed by culture.[1]

  • Renewed course of IV antibiotics for more than 7 days for pyogenic vertebral osteomyelitis: whether patients need another long IV treatment period.[1]

Why this study matters

This trial is important because it tests whether patients can move to oral treatment earlier without losing effectiveness.[1] If the early oral strategy works well, it may reduce the time patients need IV treatment and hospital-based care.[1]

For patients, the key point is that the study is not just about one medicine, but about how to safely treat a serious spinal infection with antibiotics, including SODIUM FUSIDATE as one of the oral options.[1]

Trial ID Phase Condition studied Status Enrollment
2023-507617-96-01 Phase 3 Pyogenic vertebral osteomyelitis Authorised 530

FAQ

  • What is being studied in trials of SODIUM FUSIDATE? The trial is studying whether patients with pyogenic vertebral osteomyelitis can switch earlier to oral antibiotic treatment. SODIUM FUSIDATE is one of the oral antibiotics used in the study.
  • Who can take part in these trials? The trial is for people with pyogenic vertebral osteomyelitis, which is an infection of the bones in the spine. The source data do not give more detailed entry rules.
  • What phase is the trial? This study is in Phase 3. Phase 3 trials usually compare a treatment strategy with the current standard approach in a larger group of patients.
  • What is the main goal of the trial? The main goal is to find out if early oral antibiotic treatment is non-inferior to the usual longer IV treatment. Non-inferior means it is not worse than the standard treatment by an important amount.
  • What results are being measured? The trial measures a combined outcome that includes death, spine surgery that was not planned, relapse of infection, and needing IV antibiotics again for more than 7 days. These results are tracked from the switch to oral treatment until 6 months after the oral treatment ends.

Ongoing Clinical Trials on SODIUM FUSIDATE

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

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

Glossary

  • Pyogenic vertebral osteomyelitis: A bacterial infection of the bones in the spine. 'Pyogenic' means it causes pus or is linked to pus-forming bacteria.
  • Oral antibiotic treatment: Antibiotics taken by mouth, usually as tablets or capsules.
  • Intravenous (IV) treatment: Medicine given through a vein, usually with a drip or line.
  • Phase 3: A later stage of clinical research that studies a treatment in a larger group and compares it with standard care.
  • Interventional study: A trial where researchers assign a treatment plan and then measure the results.
  • Non-inferior: A result showing a new treatment is not meaningfully worse than the standard treatment.
  • Primary outcome: The main result the researchers plan to measure to answer the study question.
  • Relapse: When the infection comes back after it seemed to improve.
  • Bacteremia: Bacteria in the blood.
  • Spine surgery: An operation on the bones or structures of the spine.

References

  1. https://clinicaltrials.gov/study/2023-507617-96-01