A Phase 4 interventional study of CAZ/AVI and CAZ/AVI in Anti-Infective Agent, sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-07-30.
Sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Phase 4, Interventional, and Treatment
Ceftazidime/avibactam (CAZ/AVI) is a new β-lactam drug, which has good antibacterial effect against carbapenem resistant enterobacter. However, previous studies found that CAZ/AVI had a low PK/PD compliance rate after the recommended dose of the drug instructions.Therefore, this study was intended to explore the clinical efficacy of different administration schedules of CAZ/AVI for patients with severe infection, and further analyze the correlation between CAZ/AVI PK/PD parameters and clinical efficacy and adverse reactions.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School is the lead sponsor of 248 studies on the registry; 146 are open to participants now.
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Multiple-resistant negative bacteria Sensitive to ceftazidime/avibactam Received intravenous infusion of ceftazidime/avibactam
Exclusion Criteria:
Allergic to ceftazidime/avibactam Blood sample not be collected Pregnant or lactating
Ceftazidime/avibactam（Taidingping®, Qilu Pharmaceutical Co., Ltd.） loading dose of 2.5g (2h infusion), then the standard dose and administration schedule, namely 2.5gQ8h, continuous infusion, the dose can be adjusted according to the instructions of renal function，The duration of medication is determined by the clinician
Drug: CAZ/AVI
Ceftazidime/avibactam（Taidingping®, Qilu Pharmaceutical Co., Ltd.）were given a load dose of 2.5g (2h infusion), followed by 2.5gQ8h, the dose can be adjusted according to renal function.The duration of medication is determined by the clinician.
Drug: CAZ/AVI
continuous infusion is used
Also known as: Continous group
2h-infusion is used
Also known as: Intermittent group
Clinical effective rate
According to the Technical Guidelines for Clinical Trials of Antimicrobial Drugs, clinical efficacy is defined as: (1) effective: symptoms, signs, pathogenic microbiology and various tests and examination indicators are significantly improved;(2) Ineffective: the patient's condition has not improved or worsened, and other antibacterial drugs need to be replaced.Effective rate = Number of effective cases/total cases x 100%.
Time frame: 14 days
Bacterial removal
Defined as clearance or change of existing bacteria within two weeks of medication.
Time frame: 14 days
28-d mortality
Defined as whether a patient died at 28-d after follow-up.28-d Mortality rate = Number of deaths/group size x 100%.
Time frame: 28 days
PK/PD compliance rate
PK/PD compliance rate = number of qualified persons/number of groups × 100%.
Time frame: 14 days
Plan to share: No
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This study is status unknown, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School →