Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06457386
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-03
Brief Title:
Echocardiography Versus no Echocardiography in S Aureus Bacteraemia and VIRSTA Score 3
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Echocardiography Versus no Echocardiography in Individuals With Staphylococcus Aureus Bacteremia and a VIRSTA Score 3 a Non-inferiority Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
VIRSTA-VAL
Brief Summary:
Staphylococcus aureus is the most frequent cause of both healthcare-associated and community-acquired bloodstream infections worldwide Infective endocarditis IE has been detected in 5-17 of cases and is a determinant of poor prognosis The investigators developed a score the VIRSTA score based on patients characteristics to rule out IE with high confidence negative predictive value NPV above 99 in patients with SAB This score with a cut-off of 3 has been externally validated by two international studies which have also established its high NPV The 2023 European society of cardiology ESC guidelines state that echocardiography should be considered in all patients with Staphylococcus aureus bacteremia SAB using risk scores including VIRSTA score to guide the use or not of echocardiography While recommended the investigators think that VIRSTA score must be evaluated in terms of patients outcome
Detailed Description:
In the interventional arm no-echocardiography strategy without echocardiography at the individual level not performing an echocardiography will avoid a useless examination the mobilization of the patient and the discomfort related to its performance
In this arm the theoretical risk is to diagnose Infective endocarditis IE only at a later phase stage ie at a phase of symptomatic manifestation of valve regurgitation or at the occurrence of relapse of bacteremia due to insufficient duration of antibiotic treatment It should be noted that patients with prosthetic valve who have de facto a VIRSTA score 3 will therefore not be included in the protocol Given the expected rarity of IE in patients with a VIRSTA score 3 and the theoretical consequences of not performing echocardiography the primary endpoint chosen will be mortality and Staphylococcus aureus bacteraemia SAB relapse The endpoint will be assessed at 90 days and not at discharge to capture relapses of inadequately treated bacteremia and the mid-term consequences of a possible delay in IE diagnosis
On a collective scale not performing echocardiography in many patients in whom it is not useful will allow resources to be allocated to the individuals who need it most
In this arm the theoretical risk is to diagnose Infective endocarditis IE only at a later phase stage ie at a phase of symptomatic manifestation of valve regurgitation or at the occurrence of relapse of bacteremia due to insufficient duration of antibiotic treatment It should be noted that patients with prosthetic valve who have de facto a VIRSTA score 3 will therefore not be included in the protocol Given the expected rarity of IE in patients with a VIRSTA score 3 and the theoretical consequences of not performing echocardiography the primary endpoint chosen will be mortality and Staphylococcus aureus bacteraemia SAB relapse The endpoint will be assessed at 90 days and not at discharge to capture relapses of inadequately treated bacteremia and the mid-term consequences of a possible delay in IE diagnosis
On a collective scale not performing echocardiography in many patients in whom it is not useful will allow resources to be allocated to the individuals who need it most
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A01572-43 | OTHER | ID-RCB | None |