Safe shortening of antibiotic treatment duration for complicated Staphylococcus aureus bacteremia (SAFE-trial)
EU CTIS ID: 2024-515398-90-01
What this study is testing
To determine whether 4 weeks of total antibiotic treatment duration is non-inferior to 6 weeks in patients with complicated SAB who have responded well to the initial treatment.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adults with methicillin-sensitive complicated SAB, defined as having at least one blood culture positive for S. aureus and one of the following conditions:
- Evidence of organ involvement and/or deep-seated infection. Examples of clinical diagnoses are: endocarditis, spondylodiscitis, arthritis, intravascular infection, abscess, and/or metastatic complications.
- Predictors of complicated SAB, defined as presence of at least one of the following risk factors for complicated SAB: a. community acquisition; b. delay > 48 hours of adequate treatment after the initial positive blood culture; c. positive follow-up blood culture > 48 hours after initiation of adequate treatment; d. persistence of fever at 72 hours after the initial positive blood culture (temperature > 38 degrees for two consecutive calendar days, measured at two time points with at least 24 hours interval, between 2 days and 7 days after the initial positive blood culture) e.unknown primary source of infection (porte d’entrée).
- 1) Satisfactory clinical response to initial treatment, defined as meeting all of the following: a) Negative blood culture for S. aureus on day 8 of adequate antibiotic treatment, defined as intravenous administration of an antibiotic agent with in-vitro activity against the cultured S. aureus. In absence of blood culture sampling on day 8, the date of first negative blood culture is the midpoint between the last positive blood culture for S. aureus and the first negative blood culture for S. aureus. b) Negative intra-operative cultures in patients with S. aureus native valve endocarditis who underwent cardiac surgery. c) C-reactive protein (CRP) decline to at least 50% below peak level or to <30 mg/L within 14 days of adequate antibiotic treatment. A high CRP due to an evident other cause, for example, an unrelated infection, is disregarded in this definition. d) Absence of fever (temperature < 38 degrees for two consecutive calendar days, measured at two time points with at least 24 hours interval) between 7 and 14 days of adequate antibiotic treatment. Fever due to unrelated, intercurrent infection (e.g. respiratory tract infection) is disregarded in this definition.
You likely can't join if
- Infected prosthetic heart valve or other infected prosthetic material which is not removed within 14 days of antibiotic therapy, as manifested by either one of the following: a) Clinical suspicion of infected prosthetic material; b) Transthoracic echocardiogram (TTE) or transesophageal echocardiogram (TEE) positive for prosthetic valve or device endocarditis; c) Positron emission tomography/computed tomography (PET/CT) scan positive for infection of prosthetic material (including prosthetic heart valve, cardiac device, vascular prosthesis or joint prosthesis).
- Presence of undrained abscess of 5 cm or more in one direction on radiological imaging at day 14 of antibiotic treatment .
- Pregnancy or lactation.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.