drugset / Trial / NCT07826351

Exploring the Combination of Intracalvariosseous and Intravenous Antibiotics for Moderate to Severe Bacterial Meningitis

NCT07826351 ↗

Not yet recruiting 9 enrolled yilong Wang
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

EvaluationDrugModalityDoseRoute
Subject Polymyxin B Peptide 100 mg Intravenous
Subject Tigecycline Small molecule 100 mg Intravenous
Subject Vancomycin Other / unclassified 2000 mg Intravenous

Indications