Status:
NOT_YET_RECRUITING
Precise Treatment of Ceftazidime-Avibactam in Patients With CRO Infections Under the Guidance of TDM and PPK Model
Lead Sponsor:
Sichuan Provincial People's Hospital
Conditions:
ECMO
Carbapenem-Resistant Enterobacteriaceae Infection
Eligibility:
All Genders
18-85 years
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 (includi...
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 patien...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06210542
Start Date
January 1 2024
End Date
December 1 2026
Last Update
January 18 2024
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