Ignite Creation Date:
2024-05-06 @ 6:29 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05681442
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2022-11-21
Brief Title:
Beta-lactam Intermittent Versus Continuous Infusion and Combination Antibiotic Therapy in Sepsis
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Beta-lactam Intermittent Versus Continuous Infusion and Combination Antibiotic Therapy in Sepsis
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BICCS
Brief Summary:
Patients hospitalized in ICU with sepsis infection with life-threatening organ dysfunction according to sepsis 30 definitions or septic shock presumably due to MDR-GNB multidrug resistant Gram-negative bacteria The study will be a prospective multicentre randomized open-label comparative continuous vs intermittent pivotal βL Beta Lactamine antibiotic infusion strategies and combination vs monotherapy trial conducted with a 2X2 factorial design
Detailed Description:
The study will be a prospective multicentre randomized open-label comparative continuous vs intermittent pivotal βL antibiotic infusion strategies and combination vs monotherapy trial conducted with a 2X2 factorial design
Patients will be randomized to one of four of the following treatment groups in a 1111 ratio Randomization will be stratified on the centre and the initial βL administered meropenem versus other to receive i βL antibiotic either as a continuous infusion CID group or as intermittent infusion IID group and ii either at most 1 dose short duration AMT group or 5 days long duration ACT group of aminoglycoside
Arm A continuous infusion dosing of a pivotal βL-AB Antibiotics CID group AND AG Aminoglycoside infusion for 5 days long duration as appropriate combination therapy ACT group
Arm B intermittent infusion dosing of a pivotal βL-AB IID control group AND AG infusion for 5 days long duration as appropriate combination therapy ACT group
Arm C continuous infusion dosing of a pivotal βL-AB CID group AND AG infusion at most 1 dose AMT group
Arm D intermittent infusion dosing of a pivotal βL-AB IID group AND AG infusion at most 1 dose AMT group
The primary objective of the study is to compare the 30-day mortality of patients with hospital-acquired sepsis in the ICU according to the mode of administration of the pivotal βL antibiotic CID group vs IID group
The primary endpoint is the mortality rate at day 30 between CID and IID groups while the Co-primary objective is to compare the MAKE 30 Major Adverse Kidney Events within 30 days between patients that will receive an appropriate monotherapy with βL AMT group or an appropriate combination therapy with βL and 5 days of AG ACT group
moreover The co-primary criterion is the percentage of patients with a MAKE 30 ie when patients met one of the following criteria within day 30 in-hospital mortality receipt of renal replacement therapy RRT or persistent renal dysfunction discharge serum creatininebaseline serum creatinine 200 between AMT and ACT groups
Patients will be randomized to one of four of the following treatment groups in a 1111 ratio Randomization will be stratified on the centre and the initial βL administered meropenem versus other to receive i βL antibiotic either as a continuous infusion CID group or as intermittent infusion IID group and ii either at most 1 dose short duration AMT group or 5 days long duration ACT group of aminoglycoside
Arm A continuous infusion dosing of a pivotal βL-AB Antibiotics CID group AND AG Aminoglycoside infusion for 5 days long duration as appropriate combination therapy ACT group
Arm B intermittent infusion dosing of a pivotal βL-AB IID control group AND AG infusion for 5 days long duration as appropriate combination therapy ACT group
Arm C continuous infusion dosing of a pivotal βL-AB CID group AND AG infusion at most 1 dose AMT group
Arm D intermittent infusion dosing of a pivotal βL-AB IID group AND AG infusion at most 1 dose AMT group
The primary objective of the study is to compare the 30-day mortality of patients with hospital-acquired sepsis in the ICU according to the mode of administration of the pivotal βL antibiotic CID group vs IID group
The primary endpoint is the mortality rate at day 30 between CID and IID groups while the Co-primary objective is to compare the MAKE 30 Major Adverse Kidney Events within 30 days between patients that will receive an appropriate monotherapy with βL AMT group or an appropriate combination therapy with βL and 5 days of AG ACT group
moreover The co-primary criterion is the percentage of patients with a MAKE 30 ie when patients met one of the following criteria within day 30 in-hospital mortality receipt of renal replacement therapy RRT or persistent renal dysfunction discharge serum creatininebaseline serum creatinine 200 between AMT and ACT groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None