EUCTR2015-004703-23-GR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-CR
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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
- 性别
- All
入选标准
- •General Inclusion Criteria:
- •Patients who fulfill the following criteria at Screening will be included in
- •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
- •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
- •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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