EUCTR2015-004703-23-ES进行中（未招募）1 期
A Multicenter, Randomized, Open-label Clinical Study of S-649266 or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens - CREDIBLE
Shionogi Ltd.0 个研究点目标入组 150 人开始时间: 2016年12月12日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
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
入选标准
- •General Inclusion Criteria:
- •Patients who fulfill the following criteria at Screening will be included in the study:
- •1. Hospitalized male and female patients, 18 years or older at the time of signing
- •informed consent
- •2. Patients who have provided written informed consent or their informed consent
- •was provided by legal guardian. (Note: Country specific rules and local Ethics
- •Committee approval for legal guardian informed consent will determine whether
- •or not and how a patient unable to comprehend or sign the informed consent is
- •allowed to be enrolled in the study)
- •3. Patients with clinically documented infection (HAP/VAP/HCAP, cUTI, or
- •BSI/sepsis) caused by a Gram-negative pathogen with evidence of carbapenem
- •4. Patients who have been treated previously with an empiric antibiotic regimen and
- •failed treatment, both clinically and microbiologically, are eligible for the study, if
- •they have an identified carbapenem-resistant , Gram-negative pathogen which has
- •either been shown to be nonsusceptible in vitro to each of the antibiotic(s) of the
- •empiric antibiotic regimen or been grown from a culture performed after at least
- •two days of the empiric antibiotic regimen
- •5. Patient is male (no contraception required) or female and meets one of the
- •following criteria:
- •- Surgically sterile by hysterectomy and/or bilateral oophorectomy or bilateral
- •salpingectomy or tubal ligation for the purpose of contraception for at least 6
- •weeks with appropriate documentation of such surgery
- •- Postmenopausal (defined as older than 45 years of age with cessation of
- •regular menstrual periods for 6 months and confirmed by a follicle-stimulating
- •hormone level of > 40 mIU/ml, or amenorrhea for at least 12 months)
- •- Of childbearing potential and using combined (estrogen and progestogen) or
- •progestogen-only hormonal contraception associated with inhibition of
- •ovulation (including oral, intravaginal, injectable, implantable, and
- •transdermal contraceptives), or an intrauterine device (IUD), or intrauterine
- •hormone-releasing system (IUS) for the entire duration of the study
- •- Of childbearing potential and practice abstinence as a preferred and usual
- •lifestyle, and agrees to continue practicing abstinence from screening up to 14
- •days after the last dose of study drug
- •- Of childbearing potential, whose sole heterosexual partner has been successfully vasectomized and agrees to not have other heterosexual partners
- •for the entire duration of the study
- •6. Patients meeting specific inclusion criteria for each infection site (See Diagnosis-
- •Specific Inclusion Criteria)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects fo
排除标准
- •General Exclusion Criteria:
- •Patients who meet any of the following criteria at Screening will be excluded from the study:
- •1.Patients who have a documented history of any moderate or severe hypersensitivity or allergic reaction to any ß-lactam (Note: for ß-lactams, a history of a mild rash followed by uneventful re-exposure is not a contraindication to enrollment)
- •2.Patients with severe neutropenia, ie, polymorphonuclear neutrophils (PMNs) < 100 cells/µL
- •3.Patients with Acute Physiology and Chronic Health Evaluation II (APACHE II) score > 30
- •4.Patients with any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the patient or the quality of the study data
- •5.Patients meeting specific exclusion criteria for each infection site
研究者
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