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Study on Oral Antibiotics Moxifloxacin, Linezolid, and Metronidazole for Patients with Bacterial Brain Abscess

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 a brain abscess, which is a collection of pus that can form in the brain due to an infection. The study aims to compare the effectiveness of oral antibiotics to intravenous (IV) antibiotics in treating this condition. The oral antibiotics being tested include Moxifloxacin, Linezolid, Metronidazole, Clindamycin, and Amoxicillin. The IV antibiotics being used in the study are Cefotaxime, Meropenem, and Ceftriaxone. A placebo may also be used in the study.

The purpose of the study is to determine if oral antibiotics are as effective as IV antibiotics in treating brain abscesses. Participants in the study will receive either oral or IV antibiotics for a period of time, and their progress will be monitored over several months. The study will assess various outcomes, including the risk of complications such as the rupture of the brain abscess, the need for additional medical procedures, and the overall recovery of the patient.

Throughout the study, participants will be regularly evaluated to ensure their safety and to monitor the effectiveness of the treatment. The study will last for a total of 52 weeks, with follow-up assessments conducted at different intervals to track the participants' health and recovery. The goal is to provide valuable information on whether oral antibiotics can be a viable alternative to IV antibiotics for treating brain abscesses, potentially offering a more convenient treatment option for patients.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, you will be assessed to ensure you meet the necessary criteria. This includes being over 17 years old, having a brain abscess confirmed by imaging, and being able to take oral medications.

    You must have already received intravenous antibiotics for at least 14 days before joining the trial, and no further surgical procedures for the brain abscess should be planned.

  2. Step 2

    Randomization

    You will be randomly assigned to receive either oral or intravenous antibiotics. This is done to compare the effectiveness of the two treatment methods.

  3. Step 3

    Treatment phase

    If assigned to oral antibiotics, you may receive medications such as moxifloxacin hydrochloride, linezolid, metronidazole, amoxicillin, or clindamycin. These are taken by mouth as tablets or capsules.

    If assigned to intravenous antibiotics, you may receive medications such as cefotaxime, meropenem anhydrous, or ceftriaxone sodium. These are administered through a vein.

    The treatment will continue for at least 14 days after randomization.

  4. Step 4

    Follow-up assessments

    You will have regular follow-up assessments to monitor your health and the effectiveness of the treatment. These assessments will occur at the end of treatment, and at 3, 6, and 12 months after randomization.

    The assessments will include checking for any recurrence of the brain abscess, any new symptoms, and overall health status.

  5. Step 5

    Completion of trial

    The trial will conclude with a final assessment at 12 months after randomization. This will help determine the long-term effectiveness and safety of the treatment you received.

Who can join the trial?

7 criteria

  • Must be older than 17 years.
  • Have symptoms and brain scans that match a brain abscess.
  • The doctor has decided to treat you for a brain abscess.
  • Must be able to take medicines by mouth.
  • Have already received recommended intravenous (IV) antimicrobials (medicines given through a vein to fight infection) for at least 14 days in a row before joining the study, and no more procedures to remove the brain abscess are planned.
  • Expected to continue treatment for at least another 14 days after joining the study.
  • No worsening of neurological problems or new neurological symptoms (except for seizures) within 5 days before joining the study.

Who cannot join the trial?

3 criteria

  • Patients with a **brain abscess** cannot participate. A brain abscess is a collection of pus that forms in the brain due to an infection.
  • Patients who are not within the specified age range for the study cannot participate. The study includes certain age groups only.
  • Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.
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Investigated drugs

  • Oral Antibiotics

    are medications taken by mouth to treat infections caused by bacteria. In this trial, they are being tested to see if they are as effective as intravenous (IV) antibiotics in treating bacterial brain abscesses. The goal is to find out if taking antibiotics by mouth can work just as well as receiving them through an IV, which is a method where medicine is given directly into a vein.

  • Intravenous (IV) Antibiotics

    are medications given directly into the bloodstream through a vein. This method is often used for serious infections because it allows the medicine to work quickly and effectively. In this trial, IV antibiotics are being compared to oral antibiotics to see if they are more effective in treating bacterial brain abscesses. The study aims to determine if the traditional IV method is necessary or if oral antibiotics can be just as effective.

What is already known about the treatment

Oral Antibiotics – Oral antibiotics are medications taken by mouth to treat infections, and in this trial, they are being tested for their effectiveness in treating bacterial brain abscesses. Currently, these antibiotics are widely used in medicine and are well-documented in medical literature for various infections. The main therapeutic indication in this trial is to treat bacterial brain abscesses. At the molecular level, oral antibiotics work by targeting and killing bacteria or stopping their growth, depending on the specific type of antibiotic. They are classified pharmacologically as antibacterial agents.

Investigated diseases

Brain abscess – A brain abscess is a collection of pus that forms in the brain due to an infection. It typically occurs when bacteria or fungi enter the brain tissue, often following an infection elsewhere in the body, head injury, or surgery. The abscess can cause swelling and inflammation, leading to increased pressure within the skull. Symptoms may include headache, fever, nausea, vomiting, neurological deficits, and changes in mental status. As the abscess progresses, it can lead to more severe neurological symptoms and complications. The condition requires careful monitoring to prevent further complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505483-11-00Estimated enrolment450 patientsSponsorAalborg University Hospital

sourced from the EU Clinical Trials Register and site verification

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