2024-515398-90-01招募中3 期
SAFE study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 15
- 主要终点
- 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.
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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.
次要结局
未报告次要终点
研究者
Jan Prins
Scientific
Stichting Amsterdam UMC
研究点 (15)
Loading locations...
相似试验
招募中
4 期
Comparison of continuing intravenous antibiotic therapy with switching to oral antibiotics in clinically stable patients with blood infections caused by Gram-negative bacteria (INVEST study)2024-517308-13-00Tan Tock Seng Hospital Pte. Ltd.150
招募中
2 期
Phase II Study of Weekly Paclitaxel/Nab-Paclitaxel, Pembrolizumab, and Mirabegron for Recurrent Ovarian CancerOvarian CancerNCT07261683Obstetrics & Gynecology Hospital of Fudan University20
招募中
4 期
Aflibercept 8mg for high-frequent Faricimab and prior Aflibercept 2mg treated Neovascular age-related macular degeneration: a monocenter, single-arm, open-label extension study (A-FAN)2024-515497-26-00Medical University Of Graz33
尚未招募
4 期
Comparison of Oral Antibiotics For Bone Infections of the Leg and FootNCT07266753Michael Garron Hospital1,418
进行中（未招募）
3 期
A randomised, phase 3 trial comparing 3-weekly docetaxel 75 mg/m2 versus 2-weekly Docetaxel 50 mg/m2 in combination with Darolutamide + ADT in patients with mHSPC (ARASAFE)prostate cancer2022-502634-52-00Friedrich-Schiller-Universitaet Jena280