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

N/ANot Yet RecruitingNCT06210542

Sichuan Provincial People's Hospital50 enrolled

Overview

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).

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

ECMO Carbapenem-Resistant Enterobacteriaceae Infection

Interventions

ceftazidime avibactamDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Clinical success rate at the end of treatment and/or the time transfer out of ICU

Clinical success includes cure or symptom improvement, which means that all symptoms and signs of patients have completely recovered or significantly improved before the end of treatment and/or the time transfer out of ICU, or imaging and other non-microbiological indicators have returned to normal. The proportion of patients with cured or improved symptoms in the total population was analyzed.

Time frame: the end of treatment or the time transfer out of ICU,up to 1 year.

Microbiologic success rate at the end of treatment and/or the time transfer out of ICU

Microbiological clearance includes clearance or presumed clearance. Clearance means that the pathogenic bacteria of the original infection have not been cultured from specimens from the original infected site after treatment; presumed clearance means that in some diseases, the disappearance of symptoms and signs makes it impossible to obtain culturable materials (such as sputum, skin pus or secretions). ), or the method of obtaining the specimen is too invasive for the recovered patient, the microbiological results are considered presumptive clearance. The microbial clearance rate is the proportion of patients who are cleared or presumed to be cleared to the total analyzed population.

Time frame: the end of treatment or the time transfer out of ICU,up to 1 year.

Secondary Outcomes

All-cause mortality on day 28 after drug initiation

All-cause mortality refers to the proportion of the total number of deaths caused by various causes within a certain period to the total analyzed population. It is necessary to count the number of deaths caused by various causes during this period as of the 28th day after the start of medication, using the Clopper-Pearson method. Calculate the 95% confidence interval for all-cause mortality on day 28 after drug initiation.

Time frame: 28 days from drug initiation

Infection-related mortality during hospitalization in ICU

Data from ClinicalTrials.gov

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