NCT04140903: ORAL

Partial Oral Antibiotic Treatment for Bacterial Brain Abscess

Recruiting now Phase 4 Last updated 30 January 2025

What this trial tests

Phase 4 trial testing Early transition to oral antibiotics in Brain Abscess in 400 participants. Currently enrolling.

Timeline

6 November 2020

Primary endpoint
31 August 2028

31 August 2028

Quick facts

Lead sponsor	Henrik Nielsen
Phase	Phase 4
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	400
Start date	6 November 2020
Primary completion	31 August 2028
Estimated completion	31 August 2028
Sites	4 locations across Denmark

Drugs / interventions tested

• Early transition to oral antibiotics — full drug profile →
• Standard treatment of intravenous antibiotics — full drug profile →

Conditions studied

• Brain Abscess — all drugs for Brain Abscess →
• Cerebral Abscess — all drugs for Cerebral Abscess →

Sponsor

Henrik Nielsen — full company profile →

Who can join

18 and older, any sex, with Brain Abscess or Cerebral Abscess. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Partial oral antibiotic treatment for bacterial brain abscess: an open-label randomized non-inferiority trial (ORAL).
   Bodilsen J, Brouwer MC, van de Beek D, Tattevin P, et al · · 2021 · cited 12× · PMID 34772441 · DOI 10.1186/s13063-021-05783-8
2. Deciphering the Intricate Interplay in the Framework of Antibiotic-Drug Interactions: A Narrative Review.
   Radu AF, Bungau SG, Corb Aron RA, Tarce AG, et al · · 2024 · cited 7× · PMID 39452205 · DOI 10.3390/antibiotics13100938
3. The use of macrolides in the treatment of community-acquired pneumonia: risks and benefits.
   Al-Zergani F, Bastrup Israelsen S, Benfield T, Fally M. · · 2025 · cited 1× · PMID 41098327 · DOI 10.1183/20734735.0190-2025
4. Short-term and long-term risk of death and readmission among adults aged 50+ years admitted with severe acute respiratory infections due to COVID-19, influenza or RSV in Denmark, 2022-2025.
   Lomholt FK, Soborg B, Valentiner-Branth P, Slotved HC, et al · · 2026 · PMID 41585308 · DOI 10.1136/bmjph-2025-004469