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

Conditions

Brain abscess

Brief summary

6-month risk of death, rupture of brain abscess, unplanned aspiration or excision of brain abscess, relapse, or recurrence.

Detailed description

Occurence of each component of the primary composite endpoint after 6 months since randomisation, All-cause mortality at 3-, 6-, and 12-months after randomisation, Unfavourable outcome at end of treatment as well as 3-, 6-, and 12-months since randomisation using sliding dichotomy of E-GOS stratified by level of comorbidity at time of randomisation, Completion and adherence to assigned treatment strategy, Line complications, Durations of admission and antibiotic treatment for brain abscess, Number of readmissions within 6 months since randomisation, 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

Related papers

No related papers found yet.

Interventions

DRUGMeropenem 2 g powder for solution for injection/infusion

DRUGCefotaxime MIP 1 g

DRUGsüste-/infusioonilahuse pulber

DRUGMoxifloxacin Tillomed 400 mg film coated tablets

DRUGLINEZOLIDE VIATRIS 600 mg

DRUGcomprimé pelliculé

DRUGClindamycin 600 mg Capsules

DRUGhard

DRUGFlagyl 500 mg κάψουλες

DRUGCEFTRIAXONE ARROW 1 g/3

DRUG5 ml

DRUGpoudre et solvant pour solution injectable (IM)

DRUGAMOXICILLIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
6-month risk of death, rupture of brain abscess, unplanned aspiration or excision of brain abscess, relapse, or recurrence.	—

Secondary

Measure	Time frame
Occurence of each component of the primary composite endpoint after 6 months since randomisation, All-cause mortality at 3-, 6-, and 12-months after randomisation, Unfavourable outcome at end of treatment as well as 3-, 6-, and 12-months since randomisation using sliding dichotomy of E-GOS stratified by level of comorbidity at time of randomisation, Completion and adherence to assigned treatment strategy, Line complications, Durations of admission and antibiotic treatment for brain abscess, Number of readmissions within 6 months since randomisation, 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	—

Measure

Time frame

Occurence of each component of the primary composite endpoint after 6 months since randomisation, All-cause mortality at 3-, 6-, and 12-months after randomisation, Unfavourable outcome at end of treatment as well as 3-, 6-, and 12-months since randomisation using sliding dichotomy of E-GOS stratified by level of comorbidity at time of randomisation, Completion and adherence to assigned treatment strategy, Line complications, Durations of admission and antibiotic treatment for brain abscess, Number of readmissions within 6 months since randomisation, 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

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Countries

Denmark, France, Netherlands, Sweden

Outcome results

None listed