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New treatment option for Brain Abscess
Official title Partial Oral Antibiotic Treatment for Bacterial Brain Abscess
ClinicalTrials.gov ID: NCT04140903
What this study is testing
What is Early transition to oral antibiotics?
Early transition to oral antibiotics is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for brain abscess.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- (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...
See the full eligibility 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.
- (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
The study team makes the final eligibility decision.
Where it's taking place
- Aalborg, Denmark
- Aarhus, Denmark
- Copenhagen, Denmark
- Odense, Denmark
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aalborg, Denmark; Aarhus, Denmark; Copenhagen, Denmark; Odense, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.