Bichat Claude Bernard Hospital
Paris, 75018, France
Location status: Recruiting
NCT Number: NCT06457386
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Paris, 75018, France
Location status: Recruiting
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, i.e., 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
"transthoracic echocardiography (TTE) will be performed as soon as possible within 14 days following the first blood sample collection for SAB diagnosis, completed, if required, by a transoesophageal (TEE) echocardiography based on the judgment of the echocardiographist.
SAB in patients of both arms will be treated according to current recommendations, taking into account the result of the echocardiography in the control arm. "
"no echocardiography will be performed unless occurrence of new events evocating IE (extra-cardiac events or positive Staphylococcus aureus blood culture), based on the clinical judgment of the investigator.
SAB in patients of both arms will be treated according to current recommendations, taking into account the result of the echocardiography in the control arm. "
Time frame: 90 Days
Time frame: 90 Days
Relapse of SAB is defined in patients with bacteriologic success as the isolation of a strain of Staphylococcus aureus with in vitro antibiotic susceptibility pattern similar to that of the Staphylococcus aureus strain isolated at inclusion. Relapse will be confirmed at the end of the study by an independent adjudication committee
Time frame: the end of hospital stay, up to 90 days
An independent adjudication committee will classify definite, possible or excluded IE according to the 2023 ESC criteria
Time frame: 90 Days
Time frame: the end of hospital stay, up to 90 days
Time frame: 90 Days
Time frame: 180 Days
Time frame: 180 Days
Time frame: 90 Days
Time frame: 90 Days
Cost-effectiveness analysis if there is a difference in the number of events in each arm
Time frame: 180 Days
Contact information is provided by the study sponsor or research team.
Assistance Publique - Hôpitaux de Paris
Other
Echocardiography Versus no Echocardiography in Individuals With Staphylococcus Aureus Bacteremia and a VIRSTA Score <3: a Non-inferiority Randomized Controlled Trial
Acronym: VIRSTA-VAL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00548002
Bacteremia, Bacterial Infections
Helsinki, HUS, Finland
View Trial DetailsNCT05184764
Bacteremia, Bacteremia Due to Staphylococcus Aureus
Tucson, Arizona, United States
View Trial DetailsNCT01198262
Bacteremia, Bacterial Infections
Houston, Texas, United States
View Trial DetailsNCT06283355
Bacterial Infections, Bacterial Infections and Mycoses
Baltimore, Maryland, United States
View Trial Details