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

NCT ID: NCT06210542

Last Updated: 2024-01-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2026-12-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 18-85 years old.

2. Hospitalized participants in ICU who did not receive Ceftazidime Avibactam treatment within 15 days before joining the study.

3. Participants with severe infection (refer to the 2022 sepsis3.0 guidelines for the definition of severe infection).

4. at least one carbapenem-resistant Gram-negative pathogen (including but not limited to carbapenem-resistant Enterobacteriaceae and / or Pseudomonas aeruginosa) was confirmed by bacterial culture in the primary infection site samples.

5. sufficient respiratory secretions, blood and peritoneal effusion can be obtained within 48 hours before the first administration for bacterial culture and drug sensitivity test.

6. intravenous injection of Ceftazidime Avibactam for more than 72 hours.

7. understand compliance with research procedures and methods, voluntarily participate in this study, and sign informed consent in writing.

Exclusion Criteria

1. Participants are less than 18.

2. Death within 72 hours after the start of treatment.

3. Known resistance to β-lactam antibacterial drugs including cephalosporins, cephalosporin compound preparations containing β-lactamase inhibitors, or Those with a history of allergies to ceftazidime avibactam sodium for injection and its excipients.

4. No indication for treatment with ceftazidime avibactam.

5. Pregnant and lactating women.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sichuan Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lingai Pan

Associate Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

LPan20230579

Identifier Type: -

Identifier Source: org_study_id