Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06528028
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
Relationship Between Different Administration Regimens of CeftazidimeAvibactam and Clinical Outcomes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Relationship Between Different Administration Regimens of CeftazidimeAvibactam and Clinical Outcomes in Patients With Severe Infection a Multicenter Prospective Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Ceftazidimeavibactam CAZAVI is a new β-lactam drug which has good antibacterial effect against carbapenem resistant enterobacter However previous studies found that CAZAVI had a low PKPD compliance rate after the recommended dose of the drug instructionsTherefore this study was intended to explore the clinical efficacy of different administration schedules of CAZAVI for patients with severe infection and further analyze the correlation between CAZAVI PKPD parameters and clinical efficacy and adverse reactions
Detailed Description:
1 Main purpose The main objective of this study was to verify that the clinical efficacy of treatment group load dose of 25g then continuous infusion of 25gQ8h 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 ceftazidimeavibactam ie 25gQ8h 2h infusionDose 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 PKPD compliance rate 3 To explore the correlation between different administration regimens and adverse drug reactions
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 PKPD compliance rate 3 To explore the correlation between different administration regimens and adverse drug reactions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None