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

NCT ID: NCT06528028

Last Updated: 2024-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2025-07-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Anti-Infective Agent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Treatment group and control group
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

A non-blind study

Study Groups

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treatment group

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

Group Type EXPERIMENTAL

CAZ/AVI

Intervention Type DRUG

continuous infusion is used

control group

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.

Group Type EXPERIMENTAL

CAZ/AVI

Intervention Type DRUG

2h-infusion is used

Interventions

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CAZ/AVI

continuous infusion is used

Intervention Type DRUG

CAZ/AVI

2h-infusion is used

Intervention Type DRUG

Other Intervention Names

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Continous group Intermittent group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ying Xu, Ph.D

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Locations

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Intensive Care Unit, Drum Tower Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ying Xu, Ph.D

Role: CONTACT

0086+(025)83106666

Facility Contacts

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Ying Xu, Ph.D

Role: primary

+86 13809043146

Other Identifiers

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EH3420202401

Identifier Type: -

Identifier Source: org_study_id

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