Brain abscess MedDRA version: 20.0 Level: PT Classification code 10006105 Term: Brain abscess System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Rocephalin
Pharmaceutical Form: Concentrate for solution for injection/infusion
INN or Proposed INN: CEFTRIAXONE
CAS Number: 73384-59-5
Other descriptive name: Ceftriaxone
Concentration un
Sponsors
Aalborg University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adults =18 years of age with bacterial brain abscess defined as: 1. A clinical presentation (e.g. headache, neurological deficit or fever) and cranial imaging (CT or MRI) consistent with brain abscess according to the hospital radiologist AND 2. The physician responsible for the patient decides to treat the patient for bacterial brain abscess Further requirements for inclusion are: 3. Ability to absorb oral medications (including by nasogastric tube) 4. To have received guideline recommended empiric or targeted (according to in-vitro susceptibility) IV antibiotic therapy for bacterial brain abscess for 14 consecutive days or longer before randomisation and no additional aspiration or excision of brain abscess planned 5. Expected to be treated with antibiotic therapy for at least another 14 days after time of randomisation 6. No progression in neurological deficits or occurrence of new-onset neurological symptoms (excluding seizures) within five days before time of randomisation Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: Patients fulfilling any of the following criteria will be excluded: 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 premenopausal women) 3. Concomitant treatment for proven or suspected CNS infection caused by mycobacteria, Nocardia spp., 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, uncontrolled HIV/AIDS (see glossary), 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We aim to conduct a randomised controlled non-inferiority trial of early transition to oral antibiotic therapy versus standard IV antibiotic treatment for six weeks or longer in patients with bacterial brain abscess in Europe. ;Secondary Objective: Not applicable;Primary end point(s): The primary outcome is 6-month risk of treatment failure defined as a composite of either death, intraventricular rupture of brain abscess, unplanned (re-)aspiration or excision of brain abscess, relapse, or recurrence. ;Timepoint(s) of evaluation of this end point: 6 months since randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints include: • Occurrence of each component of the composite primary endpoint after 6 months since randomisation • Unfavourable outcome (Extended Glasgow Outcome Scale (E-GOS) score <7) and all-cause mortality at end of treatment as well as 3-, 6-, and 12-months since randomisation • Unfavourable outcome at six months since randomisation using sliding dichotomy of E-GOS stratified by Charlson Comorbidity Index scores at time of randomisation • Completion and adherence to assigned treatment strategy (Morisky scores) • Line complications (bleeding, infection, venous thrombosis, need for replacement) during brain abscess treatment • Durations of admission and antibiotic treatment for brain abscess • Occurrence of Clostridioides difficile associated diarrhoea during brain abscess treatment • Oedema on cranial imaging at 3 months since randomisation. • Severe adverse events during brain abscess treatment • Quality of life scores and cognitive evaluations (SF-36, EQ-5D-5L, MoCA) at time of randomisation, end of treatment and 3-, 6-, and 12-months since randomisation ;Timepoint(s) of evaluation of this end point: End of treatment and at 3-, 6-, and 12-months since randomisation | — |
Countries
Australia, Denmark
Contacts
Public ContactTrial coordinator
Aalborg University Hospital
Outcome results
None listed