EUCTR2015-004703-23-GB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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 152
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
- •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 has been 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 resistance
- •4. Patients who have been treated previously with an empiric antibiotic other than the study medications, but failed treatment, both clinically and microbiologically, are eligible for the study if they have an identified pathogen which is non-susceptible to the empiric treatment and is a carbapenem-resistant Gram-negative pathogen before entering this study
- •5. Male patients who are sterile or who agreed to use an appropriate method of contraception from Screening up to 28 days after EOT or according to country specific requirements, or female patients who are surgically sterile, are postmenopausal, or females of childbearing potential who agree to use barrier contraception or who agree to use a highly-effective method of contraception from Screening up to 28 days after EOT or according to country specific requirements
- •6. Patients meeting specific criteria for each infection site
- •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 for this age range 75
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, white blood cell (WBC) < 100 cells/µL
- •3.Patients with APACHE II > 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
研究者
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