Intracalvariosseous Plus Intravenous Antibiotics for Moderate-to-Severe Bacterial Meningitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
Sponsoryilong Wang
About this trial
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.
Eligibility criteria
Qualifiers
1. Age 18-75 years, gender not limited;
GCS score ≤12 points or a decrease of 2 points from the previous score;
At least one of the following conditions is present: altered consciousness, seizures, brain parenchymal involvement, severe manifestations such as mechanical ventilation or circulatory support.
Symptoms and signs related to intracranial infection show no trend of relief or worsen;
Disqualifiers
1. History of allergy to polymyxin B, tigecycline, or vancomycin;
2. Received intrathecal or intraventricular antibiotic treatment before randomization;
3. Patients with severe pulmonary infection/acute respiratory distress syndrome (PaO₂/FiO₂ < 150 mmHg, FiO₂ ≥ 0.6, PEEP ≥ 5 cmH₂O) or whose primary cause of mechanical ventilation is not determined to be intracranial infection;
4. Patients with a primary extracranial infection focus (e.g., lungs, abdomen, urinary tract, etc.) who, after adequate fluid resuscitation, require vasoactive drugs to maintain MAP ≥ 65 mmHg (e.g., norepinephrine ≥ 0.25 μg/kg/min) and lactate > 2 mmol/L, or whose primary cause of critical illness is not determined to be intracranial infection;
Trial design
Treatments tested in this trial
- Intracalvariosseous injection vancomycin/tigecycline/polymyxin B
- Intravenous injection vancomycin/tigecycline/polymyxin B
- Conventional treatment
Treatment groups
86 Participants
are divided into 2 treatment groupsSponsors and collaborators
yilong Wang
Lead sponsor
Beijing Tiantan Hospital
Sponsor institution
Source ClinicalTrials.gov