Precise Treatment of Ceftazidime-Avibactam in Patients With CRO Infections Under the Guidance of … (NCT06210542) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Precise Treatment of Ceftazidime-Avibactam in Patients With CRO Infections Under the Guidance of TDM and PPK Model
50 participantsStarted 2024-01
Plain-language 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).
Who can participate
Age range18 Years – 85 Years
SexALL
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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.
What they're measuring
1
Clinical success rate at the end of treatment and/or the time transfer out of ICU
Timeframe: the end of treatment or the time transfer out of ICU,up to 1 year.
2
Microbiologic success rate at the end of treatment and/or the time transfer out of ICU
Timeframe: the end of treatment or the time transfer out of ICU,up to 1 year.