NCT04140903 Partial Oral Antibiotic Treatment for Bacterial Brain Abscess
| NCT ID | NCT04140903 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Henrik Nielsen |
| Condition | Brain Abscess |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2020-11-06 |
| Primary Completion | 2028-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 400 participants in total. It began in 2020-11-06 with a primary completion date of 2028-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The investigators aim to determine if oral antibiotics are clinically acceptable as treatment of brain abscess. Following 2 weeks of standard intravenous antibiotic therapy, half of patients will continue with this treatment for another 4 weeks or longer while the other half will be assigned to oral antibiotics for the remaining duration of treatment.
Eligibility Criteria
Inclusion Criteria: 1. A clinical presentation (e.g. headache, neurological deficit or fever) and cranial imaging (CT or MRI) consistent with brain abscess AND 2. The physician responsible for the patient decides to treat the patient for bacterial brain abscess AND 3. Ability to take and absorb oral medications (including by nasogastric tube) AND 4. To have received relevant antibiotic therapy for bacterial brain abscess for 14 consecutive days before randomisation AND 5. Expected to be treated with antibiotic therapy for at least another 14 days after time of randomisation AND 6. No progression in symptom intensity or occurrence of new-onset neurological symptoms (excluding seizures) within five days before time of randomisation. Exclusion Criteria (patients fulfilling either criteria): 1. Expected substantially reduced compliance with treatment (e.g. IV drug abuse) 2. Pregnancy (proven by positive urine or plasma human chorionic gonadotropin test in fertile women \<50 years of age) 3. Concomitant (empirical) brain abscess treatment for tuberculosis, nocardiosis, Pseudomonas spp., fungi, toxoplasmosis or other CNS parasites 4. Device related brain abscesses (e.g. deep brain stimulators, ventriculo-peritoneal shunts) 5. Severe immuno-compromise defined as ongoing need for biological- or chemotherapy, prednisolone \>20 mg/day for 14 days or longer, uncontrolled HIV/AIDS, haematological malignancies, and organ transplant recipients 6. Concomitant or unrelated infections necessitating IV antibiotics beyond seven days of duration after time of randomisation 7. Previous enrolment into this trial
Contact & Investigator
Jacob Bodilsen, MD
PRINCIPAL INVESTIGATOR
Aalborg University Hospital
Frequently Asked Questions
Who can join the NCT04140903 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Brain Abscess. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04140903 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04140903 currently recruiting?
Yes, NCT04140903 is actively recruiting participants. Contact the research team at jacob.bodilsen@rn.dk for enrollment information.
Where is the NCT04140903 trial being conducted?
This trial is being conducted at Aalborg, Denmark, Aarhus, Denmark, Copenhagen, Denmark, Odense, Denmark.
Who is sponsoring the NCT04140903 clinical trial?
NCT04140903 is sponsored by Henrik Nielsen. The principal investigator is Jacob Bodilsen, MD at Aalborg University Hospital. The trial plans to enroll 400 participants.