Precise Treatment of Ceftazidime-Avibactam in Patients With CRO Infections Under the Guidance of TDM and PPK Model
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ceftazidime avibactam.
- Who it may be relevant to
- Registry conditions: ECMO, Carbapenem-Resistant Enterobacteriaceae Infection. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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).
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.
Interventions
- 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
Primary outcome measures
- Clinical success rate at the end of treatment and/or the time transfer out of ICU [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 [Time frame: the end of treatment or the time transfer out of ICU,up to 1 year.]
Secondary outcome measures (7)
- All-cause mortality on day 28 after drug initiation [Time frame: 28 days from drug initiation]
- Infection-related mortality during hospitalization in ICU [Time frame: the end of treatment or the time transfer out of ICU,up to 1 year.]
- All-cause mortality on 90 days after drug initiation [Time frame: 90 days from drug initiation]
- Recurrence rate of infection on day 28 after starting medication [Time frame: 28 days from drug initiation]
- Length of ICU Stay [Time frame: the end of treatment or the time transfer out of ICU,up to 1 year.]
- Length of Hospital Stay (LOS) [Time frame: the end of treatment or the time transfer out of ICU,up to 1 year.]
- Time from ceftazidime-avibactam treatment initiation to symptom improvement [Time frame: the end of treatment or the time transfer out of ICU,up to 1 year.]
Eligibility criteria
Inclusion criteria
- 18-85 years old.
- Hospitalized participants in ICU who did not receive Ceftazidime Avibactam treatment within 15 days before joining the study.
- Participants with severe infection (refer to the 2022 sepsis3.0 guidelines for the definition of severe infection).
- 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.
- sufficient respiratory secretions, blood and peritoneal effusion can be obtained within 48 hours before the first administration for bacterial culture and drug sensitivity test.
- intravenous injection of Ceftazidime Avibactam for more than 72 hours.
- understand compliance with research procedures and methods, voluntarily participate in this study, and sign informed consent in writing.
Exclusion criteria
- Participants are less than 18.
- Death within 72 hours after the start of treatment.
- 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.
- No indication for treatment with ceftazidime avibactam.
- Pregnant and lactating women.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06210542 · LPan20230579