Relationship Between Different Administration Regimens of Ceftazidime/Avibactam and Clinical Outcomes

Nanjing University

Status and phase: Enrolling; Phase 4

Conditions: Anti-Infective Agent

Treatments: Drug: CAZ/AVI

Study type: Interventional

Funder types: Other

Identifiers

NCT06528028

EH3420202401

Details and patient eligibility

About

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.

Full description

1. Main purpose The main objective of this study was to verify that the clinical efficacy of treatment group (load dose of 2.5g, then continuous infusion of 2.5gQ8h, the dose can be adjusted according to renal function) with severe infection was superior to that of the control group (standard dose and administration regimen of ceftazidime/avibactam, i.e. 2.5gQ8h, 2h infusion).Dose can be adjusted according to renal function).
2. Secondary purpose (1) To investigate the relationship between different administration regimens and bacterial clearance and 28-d mortality (2) To explore the correlation between different dosing regimens and PK/PD compliance rate (3) To explore the correlation between different administration regimens and adverse drug reactions

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

treatment group

Experimental group

Description:

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

Treatment:

Drug: CAZ/AVI

Drug: CAZ/AVI

control group

Experimental group

Description:

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.

Treatment:

Drug: CAZ/AVI

Drug: CAZ/AVI