Partial oral antibiotic treatment for bacterial brain abscess: An open-label randomised non-inferiority trial.

Recruiting

Conditions: Brain abscsess
collection of pus in the brain
10004018
10007951

Registration Number: NL-OMON52080

Lead Sponsor: Aalborg University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 120

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

Exclusion Criteria

1. Hypersensitivity to an antibiotic intended for use in the patient and no
alternative drugs available.
2. Expected substantially reduced compliance with treatment
3. Pregnancy/ lactating women.
4. Concomitant treatment for proven or suspected CNS infection caused by
mycobacteria, Nocardia spp., Pseudomonas spp., fungi, toxoplasmosis or other
CNS parasites
5. Device related brain abscesses (e.g. deep brain stimulators,
ventriculo-peritoneal shunts)
6. 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 (see Glossary), and organ transplant
recipients
7. Concomitant or unrelated infections necessitating IV antibiotics beyond
seven days of duration after time of randomisation
8. Brain abscesses caused by Staphylococcus Aureus
9. Previous enrolment into this trial

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Treatment failure at 6 months after randomisation, consisting of:<br /><br>1. All-cause mortality<br /><br>2. Intraventricular rupture of brain abscess<br /><br>3. Unplanned re-aspiration or excision of brain abscess<br /><br>4. Relapse or recurrence</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Extended Glasgow Outcome Scale scores and all-cause mortality at end of<br /><br>treatment as well as 3-, 6-, 12-months since randomisation<br /><br>2. Completion of assigned treatment (oral vs. IV)<br /><br>3. Line associated complications (infection, thrombosis, bleeding or need for<br /><br>replacement)<br /><br>4. Durations of admission and antibiotic treatment<br /><br>5. Serious adverse events<br /><br>6. Quality of life scores and cognitive evaluations.</p><br>