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

NCT06528028 | Recruiting Phase 4 DMC

• 1 other identifier: EH3420202401
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anti-Infective Agent

Keywords

Anti-Infective Agent

Outcome Measures

Primary Outcomes (1)

• 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%.

  14 days

Secondary Outcomes (3)

• Bacterial removal

  14 days

• 28-d mortality

  28 days

• PK/PD compliance rate

  14 days

Study Arms (2)

treatment group

EXPERIMENTAL

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

control group

EXPERIMENTAL

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

Interventions

CAZ/AVI DRUG

continuous infusion is used

Also known as: Continous group

treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Multiple-resistant negative bacteria Sensitive to ceftazidime/avibactam Received intravenous infusion of ceftazidime/avibactam

You may not qualify if:

• Allergic to ceftazidime/avibactam Blood sample not be collected Pregnant or lactating

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

Intensive Care Unit, Drum Tower Hospital

Nanjing, Jiangsu, 210009, China

RECRUITING

Study Officials

• Ying Xu, Ph.D

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Xu, Ph.D

CONTACT

0086+（025）83106666; ctboycm@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: A non-blind study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Treatment group and control group

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 30, 2024
• Study Start: July 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: July 30, 2025
• Last Updated: July 30, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)