Clinical Trial

Intracalvariosseous Plus Intravenous Antibiotics for Moderate-to-Severe Bacterial Meningitis

Study acronym: FLAME
Not Yet Recruiting
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Summary
Multiple preclinical and clinical studies, including the investigators' published work and the ongoing SOLUTION series, have consistently demonstrated that intracalvariosseous (ICO) injection can markedly increase drug exposure within the central nervous system with acceptable safety. This trial is designed to further evaluate the efficacy and safety of antibiotic delivery via the ICO route in the treatment of bacterial meningitis, particularly in patients with moderate-to-severe disease who have shown an inadequate response to standard therapy.
Trial Details
NCT Number NCT07495150
Lead Sponsor yilong Wang
Conditions Blood-Brain Barrier, Bacterial Meningitis
Enrollment 86 participants
Start Date 2026-04-01
Primary Completion 2027-04-01 (estimated)
Study Completion 2027-07-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-27