Phase
Condition
Brain Tumor
Soft Tissue Infections
Treatment
Standard treatment of intravenous antibiotics
Early transition to oral antibiotics
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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.
Exclusion Criteria (patients fulfilling either criteria):
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)
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
Concomitant or unrelated infections necessitating IV antibiotics beyond seven days of duration after time of randomisation
Previous enrolment into this trial
Study Design
Study Description
Connect with a study center
Aalborg University Hospital
Aalborg,
DenmarkActive - Recruiting
Aarhus University Hospital
Aarhus,
DenmarkActive - Recruiting
Rigshospitalet
Copenhagen,
DenmarkActive - Recruiting
Odense University Hospital
Odense,
DenmarkActive - Recruiting
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