EUCTR2015-004703-23-DE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 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 resistance
- •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 and for the entire duration of the study
- •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
- •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 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
相似试验
进行中（未招募）
1 期
Study of S-649266 or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative PathogensEUCTR2015-004703-23-GRShionogi B.V.150
进行中（未招募）
1 期
Study of S-649266 or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative PathogensHospital-acquired pneumonia (HAP)/ventilator-associated pneumonia (VAP)/healthcare-associated pneumonia (HCAP) or bloodstream infections/sepsis (BSI/sepsis) caused by carbapenem-resistant Gramnegative pathogens.Complicated urinary tract infection (cUTI) caused by carbapenemresistant Gram-negative pathogens.MedDRA version: 20.0Level: LLTClassification code 10076918Term: Hospital acquired pneumoniaSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.1Level: LLTClassification code 10065153Term: Ventilator associated pneumoniaSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.0Level: HLTClassification code 10046577Term: Urinary tract infectionsSystem Organ Class: 10021881 - Infections and infestationsEUCTR2015-004703-23-ITSHIONOGI LIMITED152
进行中（未招募）
1 期
Study of S-649266 or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative PathogensHospital acquired pneumonia (HAP)/ventilator associated pneumonia (VAP)/healthcare-associated pneumonia (HCAP) or bloodstream infections/sepsis (BSI/sepsis) caused by carbapenem-resistant Gram-negative pathogens.Complicated urinary tract infection (cUTI) caused by carbapenem-resistant Gram-negative pathogens.MedDRA version: 20.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.0Level: LLTClassification code 10076918Term: Hospital acquired pneumoniaSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.1Level: LLTClassification code 10065153Term: Ventilator associated pneumoniaSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.0Level: HLTClassification code 10046577Term: Urinary tract infectionsSystem Organ Class: 10021881 - Infections and infestationsEUCTR2015-004703-23-GBShionogi B.V.152
进行中（未招募）
1 期
Study of S-649266 or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative PathogensEUCTR2015-004703-23-ESShionogi Ltd.150
进行中（未招募）
1 期
Study of S-649266 or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative PathogensEUCTR2015-004703-23-HRShionogi B.V.150