drugset / Trial / NCT07826351
Exploring the Combination of Intracalvariosseous and Intravenous Antibiotics for Moderate to Severe Bacterial Meningitis
NaSingle-groupOpen-labelTreatment
Summary
Multiple preclinical and clinical studies, including the investigators' published work and the ongoing SOLUTION series trials, have consistently demonstrated that intracalvariosseous (ICO) injection can markedly increase drug exposure in the central nervous system with an acceptable safety profile. This is a multicenter, prospective, single-arm, open-label, exploratory clinical study designed to evaluate the feasibility, safety and preliminary efficacy of antibiotic delivery via the ICO route combined with standard intravenous therapy in patients with moderate-to-severe bacterial meningitis who have shown an inadequate response to standard antibiotic treatment.
Timeline
- Start
- 2026-09-21
- Primary completion
- 2027-01-31
- Completion
- 2027-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Polymyxin B | Peptide | 100 mg | Intravenous |
| Subject | Tigecycline | Small molecule | 100 mg | Intravenous |
| Subject | Vancomycin | Other / unclassified | 2000 mg | Intravenous |