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Partial oral antibiotic treatment for bacterial brain abscess: An open-label randomised non-inferiority trial (ORAL)
EU CTIS ID: 2023-505483-11-00
What this study is testing
To determine whether oral antibiotics are non-inferior (margin 10%) to IV antibiotics for bacterial brain abscess assessed by numbers meeting a primary, objective endpoint at 6 months after randomisation
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age >17 years
- Clinical presentation and brain imaging consistent with brain abscess
- The physician in charge decides to treat the patient for brain abscess
- Able to absorb oral medications
- To have received guideline recommended intravenous antimicrobials for at least 14 consecutive days or longer before randomisation and no additional aspiraiton or excision of brain abscess planned.
- Expected to be treated for at least another 14 days after randomisation.
You likely can't join if
- Hypersensitivity to the intended antimicrobial with no other alternative drugs available
- Patients not capable of providing informed consent.
- Expected substantially reduced compliance with treatment
- Pregnancy (confirmed by urine or plasma human chorionic gonadotropin test in fertile women)
- Lactating women
- Concomitant treatment for proven or suspected CNS infection caused by mycobacteria, nocardia spp., pseudomonas spp., fungi, toxoplasmosis, or other CNS parasites
See the full eligibility criteria
- Age >17 years
- Clinical presentation and brain imaging consistent with brain abscess
- The physician in charge decides to treat the patient for brain abscess
- Able to absorb oral medications
- To have received guideline recommended intravenous antimicrobials for at least 14 consecutive days or longer before randomisation and no additional aspiraiton or excision of brain abscess planned.
- Expected to be treated for at least another 14 days after randomisation.
- No progression in neurological deficits or new-onset neurological symptoms (excluding seizures) within 5 days before randomisation
- Hypersensitivity to the intended antimicrobial with no other alternative drugs available
- Patients not capable of providing informed consent.
- Expected substantially reduced compliance with treatment
- Pregnancy (confirmed by urine or plasma human chorionic gonadotropin test in fertile women)
- Lactating women
- Concomitant treatment for proven or suspected CNS infection caused by mycobacteria, nocardia spp., pseudomonas spp., fungi, toxoplasmosis, or other CNS parasites
- Device related brain abscesses (e.g. deep brain stimulators, ventriculo-peritoneal shunts)
- Severe immuno-compromise defined as ongoing need for biological- or chemotherapy, prednisolone >20 mg/day for >14 days, uncontrolled HIV/AIDS, haematological malignancies, and organ transplant recipients
- Concomitant or unrelated infections requiring >7 days of intravenous antimicrobials
- Previous enrolment into this trial
The study team makes the final eligibility decision.
Where it's taking place
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.