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Real-World Study of Ceftazidime and Avibactam Sodium for Injection and Sodium Chloride Injection in ICU Patients with Severe Infections: Effectiveness, Safety, and Convenience

Real-World Study of Ceftazidime and Avibactam Sodium for Injection and Sodium Chloride Injection in ICU Patients with Severe Infections: Effectiveness, Safety, and Convenience

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500103407
Enrollment
Unknown
Registered
2025-05-28
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-06-02

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

Conditions

cIAI

Interventions

Observation group:None

Sponsors

Affiliated Hospital of Jinggangshan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years old; 2. ICU patients with confirmed complicated intra-abdominal infections, hospital-acquired pneumonia, or ventilator-associated pneumonia; ICU patients with Gram-negative bacterial infections (Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Proteus mirabilis, and Pseudomonas aeruginosa) that are sensitive to CAZ-AVI and have limited therapeutic options; 3. APACHE-II score >= 15 points; 4. Decided to use CAZ-AVI for infection treatment based on medical advice, and microbiological sampling was conducted before using CAZ-AVI; 5. Patients or their family members voluntarily sign informed consent forms.

Exclusion criteria

Exclusion criteria: 1. Patients with mental disorders or inability to cooperate with treatment and follow-up; 2. Individuals who are allergic to any excipients in the active substance or CAZ-AVI component. Individuals allergic to cephalosporin antibiotics. Severe hypersensitivity to other types of beta lactam antibiotics (such as penicillin, monoacylpenicillin, or carbapenems) (e.g. rapid allergic reactions, severe skin reactions); 3. Patients who have participated in other interventional treatment trials; 4. Pregnant and lactating women; 5. Patients with confirmed or suspected viral, fungal, or parasitic pneumonia; 6. Patients who, as judged by the investigator, have other diseases that may affect the assessment of efficacy, such as active pulmonary tuberculosis, cystic fibrosis of the lungs, pulmonary granulomatous diseases, lung transplantation, etc. 7. Patients with an expected survival period of less than 48 hours; 8. Patients with carbapenem resistant Acinetobacter baumannii infection; 9. Patients who, in the investigator's opinion, have any other factors that make them unsuitable for participation in this trial.

Design outcomes

Primary

MeasureTime frame
In-hospital mortality rate;White blood cell count;Clinical response rate;Discharge destination;CRP;Bacterial clearance rate;

Secondary

MeasureTime frame
Length of hospital stay;Mechanical ventilation days;PCT;IL-6;Lymphocyte count;Adverse events;SOFA score;days of vasopressor use;Convenience assessment;

Countries

China

Contacts

Public ContactHuazhang Wei

Affiliated Hospital of Jinggangshan University

Whz8830887@163.com+86 796 822 7735

Outcome results

None listed

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