Partial Oral Antibiotic Treatment for Bacterial Brain Abscess

Launched by HENRIK NIELSEN · Oct 24, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at how effective oral antibiotics are for treating bacterial brain abscesses after patients have received two weeks of standard intravenous (IV) antibiotics. A brain abscess is a collection of pus in the brain caused by an infection, and this study aims to see if switching to oral antibiotics for an additional 4 weeks (or longer) is a good option for some patients. Half of the participants will continue with the IV treatment, while the other half will take antibiotics by mouth.

To be eligible for this trial, participants must be between the ages of 65 and 74, have symptoms like headaches or fever, and show evidence of a brain abscess through imaging tests like a CT or MRI. They should also be able to take medications orally or through a feeding tube and must have already been on antibiotics for 14 days before joining the study. Those who are pregnant, have certain severe infections, or have specific medical conditions may not qualify. If you participate, you can expect close monitoring of your health and symptoms throughout the trial to help determine the best treatment options for brain abscesses in the future.

Gender

ALL

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