Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06537609
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
A Platform Trial for Gram Negative Bloodstream Infections
Sponsor:
None
Organization:
None
Study Overview
Official Title:
BALANCE A Platform Trial for Gram Negative Bloodstream Infections
Status:
RECRUITING
Status Verified Date:
2024-07
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:
BALANCE is a perpetual multiple domain randomized controlled platform trial to evaluate various treatment strategies for Gram-negative bloodstream infections GN BSIs Each domain addresses critical questions in the management of GN BSIs aiming to refine treatment strategies enhance patient outcomes and reduce antimicrobial resistance
The initial vanguard pilot RCT NCT05893147 started on 29 August 2023 and has successfully completed the pilot phase on 24-Apr-2024 All patients enrolled in the vanguard phase are part of the main platform trial
The initial vanguard pilot RCT NCT05893147 started on 29 August 2023 and has successfully completed the pilot phase on 24-Apr-2024 All patients enrolled in the vanguard phase are part of the main platform trial
Detailed Description:
BALANCE is an adaptive platform trial evaluating multiple treatment options in patients admitted to the hospital due to Gram negative bloodstream infections BSIs It focuses on both cross-cutting and subgroup-specific questions using an open-label pragmatic design embedded in routine care
BALANCE addresses the significant health concern of BSIs which have high morbidity and mortality rates exacerbated by the global public health threat of antimicrobial resistance AMR With rising resistance rates and limited new drug development effective treatment strategies for BSIs remain under-researched
BALANCE follows the BALANCE trial which evaluated duration of antibiotic treatment and aims to further investigate critical questions in managing Gram-negative BSIs This platform trial will explore various aspects of BSI treatment including antibiotic de-escalation oral antibiotic choices central line management treatment of specific pathogens and the necessity of follow-up blood cultures
BALANCE is using Bayesian methods without a fixed sample size Interim analyses will occur after every 1000th patient in each domain and then for every 200th patient thereafter The trial will stop if futility or superiority thresholds are met or if a domain reaches its ceiling sample size 2500 patients for most domains and 4000 for the beta-lactam versus non-beta-lactam domain without meeting a stopping threshold
A vanguard pilot trial involving over 150 patients at 9 hospitals across Canada confirmed the feasibility of the BALANCE trial The main trial will include patients from the vanguard pilot phase since there has been no major change in the overall study design and domains The adaptive design allows for interim analyses and adjustments by adding or removing domains as per the statistical analysis plan enhancing the trials efficiency and relevance
BALANCE addresses the significant health concern of BSIs which have high morbidity and mortality rates exacerbated by the global public health threat of antimicrobial resistance AMR With rising resistance rates and limited new drug development effective treatment strategies for BSIs remain under-researched
BALANCE follows the BALANCE trial which evaluated duration of antibiotic treatment and aims to further investigate critical questions in managing Gram-negative BSIs This platform trial will explore various aspects of BSI treatment including antibiotic de-escalation oral antibiotic choices central line management treatment of specific pathogens and the necessity of follow-up blood cultures
BALANCE is using Bayesian methods without a fixed sample size Interim analyses will occur after every 1000th patient in each domain and then for every 200th patient thereafter The trial will stop if futility or superiority thresholds are met or if a domain reaches its ceiling sample size 2500 patients for most domains and 4000 for the beta-lactam versus non-beta-lactam domain without meeting a stopping threshold
A vanguard pilot trial involving over 150 patients at 9 hospitals across Canada confirmed the feasibility of the BALANCE trial The main trial will include patients from the vanguard pilot phase since there has been no major change in the overall study design and domains The adaptive design allows for interim analyses and adjustments by adding or removing domains as per the statistical analysis plan enhancing the trials efficiency and relevance
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