NCT06210542

Precise Treatment of Ceftazidime-Avibactam in Patients With CRO Infections Under the Guidance of TDM and PPK Model

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Sichuan Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to evaluate the efficacy and safety of ceftazidime-avibactam(CAZ-AVI) in the treatment of critically ill patients with carbapenem-resistant organisms(CRO) infections (including dialysis patients and extracorporeal membrane oxygenation(ECMO) patients).

Detailed description

This is a prospective observational multicentre study. The study is to obtain the real world data of the efficacy and safety of ceftazidime-avibactam(CAZ-AVI) in the treatment of critically ill patients with carbapenem-resistant organisms(CRO) infections (including dialysis patients and extracorporeal membrane oxygenation(ECMO) patients) by using therapeutic drug monitoring(TDM). A population-pharmacokinetic(PPK) model of CAZ-AV in these patients will be established in this study. The main question it aims to answer is the clinical success rate and microbiological success rate of CAZ-AVI based regimen in the treatment of critically ill patients with CRO infections. According to the clinical practice (symptoms, signs, imaging, culture and drug sensitivity, etc.), the doctor determines the combined regimen of CAZ-AVI, and the combined drugs are used routinely according to their instructions or clinical diagnosis and treatment.

Conditions

• ECMO
• Carbapenem-Resistant Enterobacteriaceae Infection

Interventions

Type	Name	Description
DRUG	ceftazidime avibactam	Routine treatment dose for patients: the recommended intravenous dose for patients with creatinine clearance rate (eCrCL) \> 50ml/min was 2.5g (2g/0.5g), once every 8 hours, and the infusion time was 2 hours. Patients with renal injury adjust the dosage according to eCrCL

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-09-01
• Completion: 2026-12-01
• First posted: 2024-01-18
• Last updated: 2024-01-18