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Pharmacokinetic, pharmacodynamic, and efficacy of ceftazidime-avibactam in Meningitis or ventriculitis patients caused by CRE

Pharmacokinetic, pharmacodynamic, and efficacy of ceftazidime-avibactam in Meningitis or ventriculitis patients caused by carbapenem resistant Enterobacteriaceae : a prospective, multi-center clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112437
Enrollment
Unknown
Registered
2025-11-13
Start date
2025-11-13
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meningitis, Ventriculitis

Interventions

Group CZA:Receive treatment with ceftazidime-avibactam injection for 14-21 days, with the final course determined by the investigator based on the patients clinical condition. The treatment duration f

Sponsors

Huashan Hospital Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Eligible participants were aged 18–80 years, male or female. 2. Meningitis or ventriculitis due to carbapenem-resistant Enterobacteriaceae which is susceptible to ceftazidime-avibactam. 3. Those who understand the compliance with the study procedures and methods, voluntarily participate in this study, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.History of allergy to ß-lactam antimicrobials including cephalosporins, ß-lactamase inhibitor-containing cephalosporin complexes, or ceftazidime avibactam sodium for injection and its excipients. 2. Patients who refuse or are unable to collect cerebrospinal fluid, undergo continuous cerebrospinal fluid drainage (including intraventricular drainage or lumbar drainage, etc.) for cerebrospinal fluid collection and drug concentration testing. 3. Patients who have received treatment with ceftazidime-avibactam before enrollment. 4. Patients who require ECMO therapy for respiratory failure or irreversible myocardial dysfunction, etc. 5. Patients who require CRRT therapy. 6. Female patients currently in pregnancy or lactation. 7. Human immunodeficiency virus (HIV) antibody positive. 8. Any person with a physical or psychological disease or condition that, in the judgment of the investigator, is likely to increase the risk of the trial, affect the patient's compliance with the protocol, or interfere with the patient's ability to complete the trial.

Design outcomes

Primary

MeasureTime frame
Blood parameters (PK);CSF parameters (PK);Clinical response ;

Countries

China

Contacts

Public ContactJin Hu

Huashan Hospital Fudan University

hujin@fudan.edu.cn+86 21 5460 2470

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026