Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04876430
Status:
TERMINATED
Last Update Posted:
2022-08-03
First Post:
2021-05-03
Brief Title:
Best Available Therapy With or Without Meropenem for Bloodstream Infections by Enterobacterales With High Level of Resistance to Carbapenems
Sponsor:
Hospital de Clinicas de Porto Alegre
Organization:
Hospital de Clinicas de Porto Alegre
Study Overview
Official Title:
Open-label Randomized Clinical Trial Comparing Best Available Therapy With or Without Meropenem for Bloodstream Infections by Enterobacterales With Minimal Inhibitory Concentrations for Meropenem Above 32mgL
Status:
TERMINATED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Very low frequency of recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ABOVE
Brief Summary:
Enterobacterales resistant to carbapenem are cause of severe concern in hospital-acquired infections since therapeutic options are limited Recently approved drugs such as bela-lactambeta-lactamase inhibitor have been the drug of choice However its use is limited in low- and middle-income countries Thus therapy of these infections mostly relies on polymyxins and other old drugs
The role of adjuvant carbapenem therapy in combination with polymyxins aminoglycosides and other drugs is under investigation From a pharmacokineticpharmacodynamic PKPD there is an elevated probability that high-dose extended infusion administered meropenem reach the PKPD target of 40 above the minimal inhibitory concentration MIC of the pathogen when the MIC is 32mgL or lower non-susceptible isolates have MICs of 4mgL or higher However the MIC is not routinely determined in clinical laboratories In addition high-level above 32mgL resistance to carbapenems have been reported in many studies
This open-label randomized clinical trial aim to assess if the addition of meropenem to the best available therapy can increase the number of days alive and free of hospitalization in patients with bloodstream infections by Enterobacterales with MIC of meropenem above 32mgL
The role of adjuvant carbapenem therapy in combination with polymyxins aminoglycosides and other drugs is under investigation From a pharmacokineticpharmacodynamic PKPD there is an elevated probability that high-dose extended infusion administered meropenem reach the PKPD target of 40 above the minimal inhibitory concentration MIC of the pathogen when the MIC is 32mgL or lower non-susceptible isolates have MICs of 4mgL or higher However the MIC is not routinely determined in clinical laboratories In addition high-level above 32mgL resistance to carbapenems have been reported in many studies
This open-label randomized clinical trial aim to assess if the addition of meropenem to the best available therapy can increase the number of days alive and free of hospitalization in patients with bloodstream infections by Enterobacterales with MIC of meropenem above 32mgL
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None