Partial Oral Antibiotic Treatment for Bacterial Brain Abscess
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorHenrik Nielsen
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Expected substantially reduced compliance with treatment (e.g. IV drug abuse)
Pregnancy (proven by positive urine or plasma human chorionic gonadotropin test in fertile women <50 years of age)
Concomitant (empirical) brain abscess treatment for tuberculosis, nocardiosis, Pseudomonas spp., fungi, toxoplasmosis or other CNS parasites
Device related brain abscesses (e.g. deep brain stimulators, ventriculo-peritoneal shunts)
Trial design
Design model
Parallel
Treatments tested in this trial
Early transition to oral antibiotics
DrugPatients will be treated with an oral antibiotic regimen (e.g. amoxicillin + metronidazole) based upon pharmacokinetic and pharmacodynamic properties of the drugs, pathogen susceptibility, and any existing drug allergies or interactions
Standard treatment of intravenous antibiotics
DrugPatients will continue standard intravenous antibiotic therapy for brain abscess (e.g. 3rd generation cephalosporin + metronidazole) according to international guidelines and pathogen susceptibility patterns.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Oral antibioticsExperimental treatment 1 intervention
Group B: Standard treatmentActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Treatment failure
A composite of number of participants with all-cause mortality, risk of intraventricular rupture of brain abscess (IVROBA), unplanned neurosurgery, relapse, or recurrence
Time frame
Six months after randomisationSecondary outcomes
1
Treatment failure
A composite of number of participants with all-cause mortality, risk of intraventricular rupture of brain abscess (IVROBA), unplanned neurosurgery, relapse, or recurrence
Time frame
At last day of antibiotic treatment for brain abscess, and 3- and 12-months after randomisation2
Unfavourable outcome
Number of participants with Extended Glasgow Outcome Scale score \<7, overall and stratified by study centre, oral cavity bacteria (yes/no) and largest brain abscess diameter (+/- 3 cm)
Time frame
At last day of antibiotic treatment for brain abscess, and 3-, 6-, and 12-months after randomisation3
All-cause mortality
Number of participants with fatal outcome, overall and stratified by study centre, oral cavity bacteria (yes/no) and largest brain abscess diameter (+/- 3 cm)
Time frame
At last day of antibiotic treatment for brain abscess, and 3-, 6-, and 12-months after randomisation4
Unplanned neurosurgery
Number of participants with unplanned (re-)aspiration or excision, overall and stratified by study centre, oral cavity bacteria (yes/no) and largest brain abscess diameter (+/- 3 cm)
Time frame
At 6 months since randomisationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Henrik Nielsen
Lead sponsor
Aalborg University Hospital
Sponsor institution
Source ClinicalTrials.gov