EUCTR2014-004372-27-IT进行中（未招募）1 期
A Phase 3 Multicenter, Randomized, Open-label, Clinical Trial of TelavancinVersus Standard Intravenous Therapy in the Treatment of Subjects withStaphylococcus aureus Bacteremia Including Infective Endocarditis - n/a
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 248
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female at least 18 years old at the time of consent
- •2. Subject has signed an informed consent form. If a subject is unable
- •to give consent, when legally permitted, consent must be obtained from
- •the subject's legally acceptable representative.
- •NOTE: Subject, or appropriate legal representative, must be able to
- •communicate effectively with investigator and site staff
- •3. At least one blood culture positive for S. aureus obtained within 48
- •hours before randomization, referred to as the qualifying blood culture
- •4. In addition to the QBC, subject must have at least one of the
- •following signs or symptoms of bacteremia:
- •Temperature = 38.0°C
- •White blood cell (WBC) count > 10,000 or < 4,000 cells/µL, or > 10%
- •immature neutrophils (bands) regardless of total peripheral WBC count
- •Tachycardia (heart rate > 90 bpm)
- •Tachypnea (respiratory rate >20 breaths/min)
- •Hypotension (systolic blood pressure <90 mmHg)
- •Signs and symptoms of localized catheter-related infection
- •(tenderness and/or pain, erythema, swelling, purulent exudate within 2
- •cm of entry site)
- •5. Subject must, at enrollment, have either 1) known right-sided
- •infective endocarditis by Modified Duke's Criteria, 2) known complicated
- •bacteremia, demonstrated as signs or symptoms of metastatic foci of S.
- •aureus infection (eg, any infection remote from the primary focus caused
- •by hematogenous seeding or extension of infection beyond the primary
- •focus), or 3) at least one of the following risk factors for complicated
- •bacteremia [25-28].
- •A central venous catheter (CVC) in the internal jugular or subclavian
- •vein (Note: peripheral venous catheters are not sufficient for
- •enrollment)
- •Any CVC considered to be the source of the infection, demonstrated
- •by inflammation or purulent drainage from the CVC insertion site
- •Presence of a long-term intravascular catheter (eg, tunneled cuffed
- •intravascular catheter or subcutaneous port catheter); must be removed
- •within 3 days after enrollment
- •New or diastolic cardiac murmur
- •Community onset bacteremia (eg, subject does not live in a
- •healthcare facility)
- •Pathogen known to be MRSA at enrollment
- •Duration of symptoms =2 days at time of presentation (prior to start
- •of antibiotic therapy)
- •Skin exam findings suggesting acute systemic infection (ie, petechiae,
- •vasculitis, infarcts, ecchymoses or pustules due to the infection)
- •6. Willing to receive intravenous antibiotics for the duration of
- •7. Expected survival of at least 3 months
- •8. Female subjects must be non-pregnant and non-lactating. If a female
- •subject is of childbearing potential, must have a documented negative
- •pregnancy test at screening
- •NOTE: All females are considered to be of childbearing potential unless
- •they are postmenopausal (amenorrheic for at least 2 years) or
- •documented to be surgically sterile (bilateral tubal ligation or total
- 另有 11 项未显示
排除标准
- •1. Treatment with any potentially effective (anti-staphylococcal)
- •systemic antibiotic for more than 48 hours within 7 days before
- •randomization
- •EXCEPTION: Documented resistance to the prior systemic antibacterial
- •therapy, confirmed by a microbiological laboratory report (pathogens
- •non susceptible to telavancin, or non-susceptible to daptomycin and a
- •vancomycin MIC >1 mcg/mL are not permitted)
- •2. Requirement or anticipated requirement of potentially effective
- •(anti-staphylococcal) non-study systemic antibiotics during the study
- •3. Presence of an infection source (eg, intravascular line, abscess,
- •infected prosthetic material, wound) that will not be managed or
- •controlled (eg, removal of line, drainage of abscess, removal of infected
- •prosthesis, or debridement of wound) within the first 3 days of study
- •drug treatment
- •4. Presence of prosthetic cardiac valve or cardiac device (eg,
- •implantable cardioverter defibrillator [ICD]), permanent pacemaker, or
- •cardiac valve support ring)
- •5. Known or suspected left-sided infective endocarditis (LIE), according
- •to Modified Duke Criteria (Appendix 1)
- •NOTE: Right-sided infective endocarditis (RIE) is permitted
- •6. Known or suspected osteomyelitis or meningitis
- •NOTE: Investigators should use clinical judgment to determine whether
- •additional imaging studies (eg, X-ray, computed tomography scan,
- •magnetic resonance imaging) are indicated at screening to rule out the
- •presence of osteomyelitis
- •NOTE: Evidence of metastatic complications related to the primary
- •infection such as right-sided endocarditis, septic arthritis, septic
- •pulmonary emboli are permitted. S. aureus pneumonia is permitted
- •7. Prior episode of invasive S. aureus infection (defined as having
- •resolved after appropriate follow-up per discretion of the investigator)
- •within the past 30 days
- •8. Infecting pathogen with confirmed (prior to enrollment) nonsusceptibility
- •to telavancin; or confirmed non susceptibility to
- •daptomycin and a vancomycin MIC >1 mcg/mL; or a mixed polymicrobial
- •infection with a Gram-negative pathogen with confirmed resistance to
- •9. Subjects with HIV/AIDS requiring prophylactic
- •trimethoprim/sulfamethoxazole are excluded (or requiring potentially
- •effective concomitant administration of agents containing cyclodextrin
- •(eg, itraconazole, voriconazole)
- •10. Previous participation in an anti-infective study during the past 12
- •11. A history of significant allergy or intolerance to telavancin; caution
- •should be taken in subjects with a history of severe hypersensitivity
- •reaction to vancomycin. If the pathogen is known MRSA, allergy to both
- •vancomycin and daptomycin. If the pathogen is known MSSA, allergy to
- •both anti-staphylococcal PCN/cephalosporin and daptomycin
- •12. Solid organ transplantation or bone marrow transplantation within
- •6 months before randomization
- •13. Severe neutropenia, defined as an absolute neutrophil count (ANC)
- •<500 cells per microliter, or expected development of severe
- •neutropenia during study
- 另有 8 项未显示
研究者
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