Brain AbscessPhase 4ORALNCT04140903
Partial Oral Antibiotic Treatment for Bacterial Brain Abscess
A Phase 4 study testing Early transition to oral antibiotics and Standard treatment of intravenous antibiotics in people with Brain Abscess and Cerebral Abscess, run by Henrik Nielsen at 4 sites in Denmark.
Trial summary
The investigators aim to determine if oral antibiotics are clinically acceptable as treatment of brain abscess. Following 2 weeks of standard intravenous antibiotic therapy, half of patients will continue with this treatment for another 4 weeks or longer while the other half will be assigned to oral antibiotics for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Abscess, Cerebral Abscess
- What is being tested?
- Early transition to oral antibiotics and Standard treatment of intravenous antibiotics
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 4 sitesDenmark
- Study dates
- 6 Nov 2020to 31 Aug 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark4 sites, 4 recruiting
- Recruiting
Aalborg University Hospital
Aalborg
Jacob Bodilsen, MD PhD
- Recruiting
Aarhus University Hospital
Aarhus
Merete Storgaard, MD
- Recruiting
Rigshospitalet
Copenhagen
Lars H Omland, MD
- Recruiting
Odense University Hospital
Odense
Lykke Larsen, MD
About this study
Official title: Partial Oral Antibiotic Treatment for Bacterial Brain Abscess: an Open-label Randomised Non-inferiority Trial
The investigators aim to determine if oral antibiotics are clinically acceptable as treatment of brain abscess. Following 2 weeks of standard intravenous antibiotic therapy, half of patients will continue with this treatment for another 4 weeks or longer while the other half will be assigned to oral antibiotics for the remaining duration of treatment.
Read the detailed description
Treatment of brain abscess remains a considerable challenge due to the precarious location of the infection and the impenetrability of the blood-brain-barrier for most drugs. Thus, cure usually requires a combination of neurosurgical evacuation of abscess material and 6-8 weeks of high-dose intravenous (IV) antibiotic therapy to ensure eradication of bacteria within the abscess cavity. Disadvantages include risks of nosocomial infections and line-associated complications (e.g. bleeding, venous thrombosis, or need for replacement due to malfunction) in addition to the considerable costs of such long-term admission. However, improved insights into the pharmacokinetic properties and favourable bioavailability of some oral antibiotics may allow such treatment at an early stage. To date, there are no randomised controlled trials to guide treatment of bacterial brain abscess.
The investigators wish to determine whether a treatment strategy of transition to oral antibiotics after two weeks of treatment is non-inferior to continued IV antibiotics in clinically stable brain abscess patients assessed by the proportion with a favourable outcome at six months since randomisation.
- Conditions
- Brain Abscess, Cerebral Abscess
- Being tested
- Early transition to oral antibiotics, Standard treatment of intravenous antibiotics
- Keywords
- Oral antibiotics
- Medical subject headings
- Brain Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early transition to oral antibioticsDrug
Patients will be treated with an oral antibiotic regimen (e.g. amoxicillin + metronidazole) based upon pharmacokinetic and pharmacodynamic properties of the drugs, pathogen susceptibility, and any existing drug allergies or interactions
Standard treatment of intravenous antibioticsDrug
Patients will continue standard intravenous antibiotic therapy for brain abscess (e.g. 3rd generation cephalosporin + metronidazole) according to international guidelines and pathogen susceptibility patterns.
| Study group | Role | What they receive |
|---|---|---|
| Oral antibiotics | Experimental | Patients will be randomised to oral antibiotics after two weeks of appropriate antibiotic therapy for bacterial brain abscess since definitive aspiration/excision of brain abscess or, in case of no planned diagnostic neurosurgical procedure, since initiation of guideline recommended antibiotics for bacterial brain abscess Receives: Drug: Early transition to oral antibiotics |
| Standard treatment | Active comparator | Patients will be randomised to continuation of standard intravenous antibiotics after two weeks of appropriate antibiotic therapy for bacterial brain abscess since definitive aspiration/excision of brain abscess or, in case of no planned diagnostic neurosurgical procedure, since initiation of guideline recommended antibiotics for bacterial brain abscess Receives: Drug: Standard treatment of intravenous antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure
A composite of number of participants with all-cause mortality, risk of intraventricular rupture of brain abscess (IVROBA), unplanned neurosurgery, relapse, or recurrence
Measured: Six months after randomisation
Secondary outcomes (19)
Treatment failure
A composite of number of participants with all-cause mortality, risk of intraventricular rupture of brain abscess (IVROBA), unplanned neurosurgery, relapse, or recurrence
Measured: At last day of antibiotic treatment for brain abscess, and 3- and 12-months after randomisation
Unfavourable outcome
Number of participants with Extended Glasgow Outcome Scale score <7, overall and stratified by study centre, oral cavity bacteria (yes/no) and largest brain abscess diameter (+/- 3 cm)
Measured: At last day of antibiotic treatment for brain abscess, and 3-, 6-, and 12-months after randomisation
All-cause mortality
Number of participants with fatal outcome, overall and stratified by study centre, oral cavity bacteria (yes/no) and largest brain abscess diameter (+/- 3 cm)
Measured: At last day of antibiotic treatment for brain abscess, and 3-, 6-, and 12-months after randomisation
Unplanned neurosurgery
Number of participants with unplanned (re-)aspiration or excision, overall and stratified by study centre, oral cavity bacteria (yes/no) and largest brain abscess diameter (+/- 3 cm)
Measured: At 6 months since randomisation
IVROBA
Number of participants with intraventricular rupture of brain abscess, overall and stratified by study centre, oral cavity bacteria (yes/no) and largest brain abscess diameter (+/- 3 cm)
Measured: At 6 months since randomisation
Relapse
Number of participants with increase in brain abscess volume by 20% since randomisation, clinical deterioration attributable to brain abscess or lack of cure of at least 4 weeks or longer of assigned study treatment, overall and stratified by study centre, oral cavity bacteria (yes/no) and largest brain abscess diameter (+/- 3 cm)
Measured: At 6 months since randomisation
Recurrence
New brain abscess formation after end of treatment, overall and stratified by study centre, oral cavity bacteria (yes/no) and largest brain abscess diameter (+/- 3 cm)
Measured: At 6 months since randomisation
Unfavourable outcome - sliding dichotomy
Sliding dichotomy of extended Glasgow Outcome Scale scores according to Charlson comorbidity index score (range: 0=no comorbidity and more likely to have a favourable outcome to 40=high degree of comorbidity with a poor prognosis of a favourable outcome) at time of randomisation (0 vs. 1-2 vs. >2).
Measured: At last day of antibiotic treatment for brain abscess, and 3-, 6-, and 12-months after randomisation
Central line associated complications
Number of participants with bleeding, infection, venous thrombosis or need for replacement of central line due to mechanical malfunction
Measured: 6 months since randomisation
Clostridial diarrhea
Number of participants who develop Clostridioides difficile associated gastro-enteritis during antibiotic treatment for brain abscess
Measured: From randomisation up until last day antibiotic treatment for brain abscess
Duration of admission
Days spent as admitted patient in hospital up to 6 months since randomisation (does not include outpatient hospital care)
Measured: From randomisation until hospital discharge to home or rehabilitation unit or death, whichever comes first, assessed up to 6 months
Duration of treatment
Number of days treated with antibiotics for brain abscess up to 6 months since randomisation
Measured: From randomisation until last day of antibiotic treatment for brain abscess up to 6 months since randomisation
Adherence to treatment
Adherence to allocated treatment. For oral treatment this will be measured using Morisky 8-item Medication Adherence scale scores (range 0=high adherence to 8=low adherence) up to 6 months since randomisation
Measured: From randomisation until last day of antibiotic treatment for brain abscess, assessed up to 6 months since randomisation
Oedema on cranial imaging
Number of participants with residual perilesional oedema on cranial imaging up to 3 months since randomisation
Measured: 3 months since randomisation
SAE
Number of participants with severe adverse events
Measured: From randomisation until last day of antibiotic treatment for brain abscess
SF36
Short Form 36 is a 36 item survey of patient-reported health-related quality of life (range 0=maximum disability to 100=no disability)
Measured: At time of randomisation, last day of antibiotic treatment for brain abscess, and 3-, 6-, and 12-months since randomisation
EQ-5D-5L
EuroqQol - 5 dimensions - 5 level scores are derived from a standardized instrument for measuring generic health status including mobility, self-care, usual acitivities, pain/discomfort, and anxiety/depression (range 5=good health status to 25=poor health status)
Measured: At time of randomisation, last day of antibiotic treatment for brain abscess, and 3-, 6-, and 12-months since randomisation
EQ-VAS
EuroqQol Visual Analogue Scale (range 0=poor health status to 100=excellent health status)
Measured: At time of randomisation, last day of antibiotic treatment for brain abscess, and 3-, 6-, and 12-months since randomisation
Cognitive impairment
Montreal Cognitive Assessment (MoCA) scores (range 0=poor cognitive performance to 30=normal cognitive performance)
Measured: At time of randomisation, last day of antibiotic treatment for brain abscess, and 3-, 6-, and 12-months since randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start6 Nov 2020
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain AbscessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Investigator-initiated, international, multi-centre, randomised, parallel groups, non-inferiority trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henrik Nielsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Henrik Nielsen, Aalborg University Hospital
- Investigators
- Jacob Bodilsen, MD, Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04140903
- Sponsor's protocol ID
- 1
- Acronym
- ORAL
- Status last verified
- Jan 2025
- First submitted
- 4 Jul 2019
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Beginning six months and ending three years after publication, an anonymized dataset can be shared with qualified researchers who provide a methodologically sound proposal for a post-hoc study assessed by the members of the steering committee. The anonymized dataset will include baseline demographics of patients, laboratory results, treatments and primary outcome at six months since randomisation. In addition, the study protocol, statistical analysis plan, informed consent form, clinical study report and analytic code can also be shared. Proposals should be directed to the trial manager. To gain access, data requestors will need to sign a data access agreement. Data will be deposited at Mendeley Data (https://data.mendeley.com/).
Publications
Bodilsen J, Brouwer MC, van de Beek D, Tattevin P, Tong S, Naucler P, Nielsen H. Partial oral antibiotic treatment for bacterial brain abscess: an open-label randomized non-inferiority trial (ORAL). Trials. 2021 Nov 12;22(1):796. doi: 10.1186/s13063-021-05783-8.
PubMed 34772441
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partial Oral Antibiotic Treatment for Bacterial Brain Abscess: an Open-label Randomised Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT04140903
- Acronym / sponsor ID
- ORAL / 1
- Conditions
- Brain Abscess, Cerebral Abscess
- Keywords
- Oral antibiotics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Henrik NielsenUniversity, hospital or other
- Study start
- 6 Nov 2020 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 28 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aim to determine if oral antibiotics are clinically acceptable as treatment of brain abscess. Following 2 weeks of standard intravenous antibiotic therapy, half of patients will continue with this treatment for another 4 weeks or longer while the other half will be assigned to oral antibiotics for the remaining duration of treatment.
Detailed description
Treatment of brain abscess remains a considerable challenge due to the precarious location of the infection and the impenetrability of the blood-brain-barrier for most drugs. Thus, cure usually requires a combination of neurosurgical evacuation of abscess material and 6-8 weeks of high-dose intravenous (IV) antibiotic therapy to ensure eradication of bacteria within the abscess cavity. Disadvantages include risks of nosocomial infections and line-associated complications (e.g. bleeding, venous thrombosis, or need for replacement due to malfunction) in addition to the considerable costs of such long-term admission. However, improved insights into the pharmacokinetic properties and favourable bioavailability of some oral antibiotics may allow such treatment at an early stage. To date, there are no randomised controlled trials to guide treatment of bacterial brain abscess.
The investigators wish to determine whether a treatment strategy of transition to oral antibiotics after two weeks of treatment is non-inferior to continued IV antibiotics in clinically stable brain abscess patients assessed by the proportion with a favourable outcome at six months since randomisation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Investigator-initiated, international, multi-centre, randomised, parallel groups, non-inferiority trial
| Arm | Type | Receives |
|---|---|---|
| Oral antibiotics | Experimental | Drug: Early transition to oral antibioticsPatients will be randomised to oral antibiotics after two weeks of appropriate antibiotic therapy for bacterial brain abscess since definitive aspiration/excision of brain abscess or, in case of no planned diagnostic neurosurgical procedure, since initiation of guideline recommended antibiotics for bacterial brain abscess |
| Standard treatment | Active comparator | Drug: Standard treatment of intravenous antibioticsPatients will be randomised to continuation of standard intravenous antibiotics after two weeks of appropriate antibiotic therapy for bacterial brain abscess since definitive aspiration/excision of brain abscess or, in case of no planned diagnostic neurosurgical procedure, since initiation of guideline recommended antibiotics for bacterial brain abscess |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early transition to oral antibioticsPatients will be treated with an oral antibiotic regimen (e.g. amoxicillin + metronidazole) based upon pharmacokinetic and pharmacodynamic properties of the drugs, pathogen susceptibility, and any existing drug allergies or interactions | Drug | Oral antibiotics |
| Standard treatment of intravenous antibioticsPatients will continue standard intravenous antibiotic therapy for brain abscess (e.g. 3rd generation cephalosporin + metronidazole) according to international guidelines and pathogen susceptibility patterns. | Drug | Standard treatment |
Primary outcome
Treatment failure
Time frame: Six months after randomisation
A composite of number of participants with all-cause mortality, risk of intraventricular rupture of brain abscess (IVROBA), unplanned neurosurgery, relapse, or recurrence
19 secondary outcomes
Treatment failure
Time frame: At last day of antibiotic treatment for brain abscess, and 3- and 12-months after randomisation
Unfavourable outcome
Time frame: At last day of antibiotic treatment for brain abscess, and 3-, 6-, and 12-months after randomisation
All-cause mortality
Time frame: At last day of antibiotic treatment for brain abscess, and 3-, 6-, and 12-months after randomisation
Unplanned neurosurgery
Time frame: At 6 months since randomisation
IVROBA
Time frame: At 6 months since randomisation
Relapse
Time frame: At 6 months since randomisation
Recurrence
Time frame: At 6 months since randomisation
Unfavourable outcome - sliding dichotomy
Time frame: At last day of antibiotic treatment for brain abscess, and 3-, 6-, and 12-months after randomisation
Central line associated complications
Time frame: 6 months since randomisation
Clostridial diarrhea
Time frame: From randomisation up until last day antibiotic treatment for brain abscess
Duration of admission
Time frame: From randomisation until hospital discharge to home or rehabilitation unit or death, whichever comes first, assessed up to 6 months
Duration of treatment
Time frame: From randomisation until last day of antibiotic treatment for brain abscess up to 6 months since randomisation
Adherence to treatment
Time frame: From randomisation until last day of antibiotic treatment for brain abscess, assessed up to 6 months since randomisation
Oedema on cranial imaging
Time frame: 3 months since randomisation
SAE
Time frame: From randomisation until last day of antibiotic treatment for brain abscess
SF36
Time frame: At time of randomisation, last day of antibiotic treatment for brain abscess, and 3-, 6-, and 12-months since randomisation
EQ-5D-5L
Time frame: At time of randomisation, last day of antibiotic treatment for brain abscess, and 3-, 6-, and 12-months since randomisation
EQ-VAS
Time frame: At time of randomisation, last day of antibiotic treatment for brain abscess, and 3-, 6-, and 12-months since randomisation
Cognitive impairment
Time frame: At time of randomisation, last day of antibiotic treatment for brain abscess, and 3-, 6-, and 12-months since randomisation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Derived from this study: PubMed 34772441Bodilsen J, Brouwer MC, van de Beek D, Tattevin P, Tong S, Naucler P, Nielsen H. Partial oral antibiotic treatment for bacterial brain abscess: an open-label randomized non-inferiority trial (ORAL). Trials. 2021 Nov 12;22(1):796. doi: 10.1186/s13063-021-05783-8.
- Individual participant dataSharing planned: Yes. Beginning six months and ending three years after publication, an anonymized dataset can be shared with qualified researchers who provide a methodologically sound proposal for a post-hoc study assessed by the members of the steering committee. The anonymized dataset will include baseline demographics of patients, laboratory results, treatments and primary outcome at six months since randomisation. In addition, the study protocol, statistical analysis plan, informed consent form, clinical study report and analytic code can also be shared. Proposals should be directed to the trial manager. To gain access, data requestors will need to sign a data access agreement. Data will be deposited at Mendeley Data (https://data.mendeley.com/).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jacob Bodilsen, MD principal investigator
Aalborg University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Early transition to oral antibiotics and Standard treatment of intravenous antibiotics in people with Brain Abscess and Cerebral Abscess, run by Henrik Nielsen at 4 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacob Bodilsen, MD (+45 97663920, jacob.bodilsen@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure (time frame: Six months after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04140903, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.