2024-515398-90-01
Recruiting
Phase 3
SAFE study
Stichting Amsterdam UMC15 sites in 1 country300 target enrollmentStarted: August 14, 2024Last updated:
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Stichting Amsterdam UMC
- Enrollment
- 300
- Locations
- 15
- Primary Endpoint
- The primary outcome is success of therapy, defined at 180 days after randomization by presence of the following: 1. Patient alive. 2. No evidence of microbiologically confirmed disease relapse, defined as symptoms and/or signs of infection, after initial clinical improvement, with S. aureus isolated from blood or another normally sterile site (e.g. joint fluid, tissue) by conventional culture.
Overview
Brief Summary
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.
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
The primary outcome is success of therapy, defined at 180 days after randomization by presence of the following: 1. Patient alive. 2. No evidence of microbiologically confirmed disease relapse, defined as symptoms and/or signs of infection, after initial clinical improvement, with S. aureus isolated from blood or another normally sterile site (e.g. joint fluid, tissue) by conventional culture.
The primary outcome is success of therapy, defined at 180 days after randomization by presence of the following: 1. Patient alive. 2. No evidence of microbiologically confirmed disease relapse, defined as symptoms and/or signs of infection, after initial clinical improvement, with S. aureus isolated from blood or another normally sterile site (e.g. joint fluid, tissue) by conventional culture.
Secondary Outcomes
No secondary outcomes reported
Investigators
Jan Prins
Scientific
Stichting Amsterdam UMC
Study Sites (15)
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