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

Phase 1

Recruiting

• Conditions: Brain abscess; MedDRA version: 20.0Level: LLTClassification code: 10006106Term: Brain abscess NOS Class: 10021881; MedDRA version: 20.0Level: PTClassification code: 10006105Term: Brain abscess Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: CTIS2023-505483-11-00
• Lead Sponsor: Aalborg University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-27
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

Age >17 years, Clinical presentation and brain imaging consistent with brain abscess, The physician in charge decides to treat the patient for brain abscess, Able to absorb oral medications, To have received guideline recommended intravenous antimicrobials for at least 14 consecutive days or longer before randomisation and no additional aspiraiton or excision of brain abscess planned., Expected to be treated for at least another 14 days after randomisation., No progression in neurological deficits or new-onset neurological symptoms (excluding seizures) within 5 days before randomisation

Exclusion Criteria

Hypersensitivity to the intended antimicrobial with no other alternative drugs available, Patients not capable of providing informed consent., Expected substantially reduced compliance with treatment, Pregnancy (confirmed by urine or plasma human chorionic gonadotropin test in fertile women), Lactating women, Concomitant treatment for proven or suspected CNS infection caused by mycobacteria, nocardia spp., 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, uncontrolled HIV/AIDS, haematological malignancies, and organ transplant recipients, Concomitant or unrelated infections requiring >7 days of intravenous antimicrobials, Previous enrolment into this trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether oral antibiotics are non-inferior (margin 10%) to IV antibiotics for bacterial brain abscess assessed by numbers meeting a primary, objective endpoint at 6 months after randomisation;Secondary Objective: To determine the proportions of patients with favourable outcome and all-cause mortalities during 1 year of follow-up, completion of allocated treatment (oral or IV), safety, and quality of life assessed by secondary endpoints;Primary end point(s): 6-month risk of death, rupture of brain abscess, unplanned aspiration or excision of brain abscess, relapse, or recurrence.