Partial Oral Antibiotic Treatment for Bacterial Brain Abscess: an Open-label Randomised Non-inferiority Trial

Who is this study for? Adult patients with brain abscesses
What treatments are being studied? Early transition to oral antibiotics
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• A clinical presentation (e.g. headache, neurological deficit or fever) and cranial imaging (CT or MRI) consistent with brain abscess AND

• The physician responsible for the patient decides to treat the patient for bacterial brain abscess AND

• Ability to take and absorb oral medications (including by nasogastric tube) AND

• To have received relevant antibiotic therapy for bacterial brain abscess for 14 consecutive days before randomisation AND

• Expected to be treated with antibiotic therapy for at least another 14 days after time of randomisation AND

• No progression in symptom intensity or occurrence of new-onset neurological symptoms (excluding seizures) within five days before time of randomisation.

Locations
Other Locations
Denmark
Aalborg University Hospital
RECRUITING
Aalborg
Aarhus University Hospital
RECRUITING
Aarhus
Rigshospitalet
RECRUITING
Copenhagen
Odense University Hospital
RECRUITING
Odense
Contact Information
Primary
Jacob Bodilsen, MD
jacob.bodilsen@rn.dk
+45 97663920
Backup
Henrik Nielsen, Professor
henrik.nielsen@rn.dk
+45 97663920
Time Frame
Start Date: 2020-11-06
Estimated Completion Date: 2028-08-31
Participants
Target number of participants: 400
Treatments
Experimental: Oral antibiotics
Patients will be randomised to oral antibiotics after two weeks of appropriate antibiotic therapy for bacterial brain abscess since definitive aspiration/excision of brain abscess or, in case of no planned diagnostic neurosurgical procedure, since initiation of guideline recommended antibiotics for bacterial brain abscess
Active_comparator: Standard treatment
Patients will be randomised to continuation of standard intravenous antibiotics after two weeks of appropriate antibiotic therapy for bacterial brain abscess since definitive aspiration/excision of brain abscess or, in case of no planned diagnostic neurosurgical procedure, since initiation of guideline recommended antibiotics for bacterial brain abscess
Related Therapeutic Areas
Sponsors
Leads: Henrik Nielsen

This content was sourced from clinicaltrials.gov