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Pharmacokinetic/pharmacodynamic study of ceftazidime/avibactam in critically ill patients receiving continuous renal replacement therapy

Pharmacokinetic/pharmacodynamic study of ceftazidime/avibactam in critically ill patients receiving continuous renal replacement therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500101985
Enrollment
Unknown
Registered
2025-05-07
Start date
2025-05-09
Completion date
Unknown
Last updated
2025-05-12

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

Conditions

Infections

Interventions

Observation group:None

Sponsors

Zhongda Hospital, Southeast University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: Entry Criteria: 1) Age 18-85 years old; 2) Male or female; 3) Patients with severe infections (refer to 2016 sepsis 3.0 guidelines for criteria defining severe infections); 4) Primary infection site specimen confirmed or proposed by bacterial culture for at least one carbapenem-resistant gram-negative pathogen (including but not limited to carbapenem-resistant Enterobacteriaceae and/or Pseudomonas aeruginosa) that is susceptible to ceftazidime/avibactam; 5) Patients receiving continuous renal replacement therapy on the day of therapeutic drug monitoring 6) Sufficient samples of respiratory secretions, blood, and peritoneal fluid can be obtained for bacterial culture and drug sensitivity testing within 48 hours prior to the first dose; 7) Received ceftazidime avibactam continuously for = 72 hours; 8) Those who understand the compliance with the study procedures and methods, participate in the study voluntarily, and sign a written informed consent form.

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1) Patients who have not undergone blood concentration monitoring of ceftazidime/avibactam during treatment; 2) Patients with a history of severe allergy, hypersensitivity to ceftazidime/avibactam API or other components of the formulation; 3) Serious illness or expected survival of no more than 48 hours; 4) Pregnant (positive urine or serum ß-hCG test prior to randomization) or breastfeeding females; 5) other conditions that, in the opinion of the investigator, make enrollment inappropriate.

Design outcomes

Primary

MeasureTime frame
PTA;Microbial clearance;28-day mortality rate;

Countries

China

Contacts

Public ContactLinlin Hu

Zhongda Hospital, Southeast University

eliza50@sina.com+86 136 7513 2851

Outcome results

None listed

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