EUCTR2015-004703-23-IT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
SHIONOGI LIMITED0 个研究点目标入组 152 人开始时间: 2018年2月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 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
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 folliclestimulating hormone level of > 40 mIU/ml, or amenorrhea for at least 12
- •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
- •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 who need more than 3 systemic antibiotics as part of BAT for the treatment of the Gram-negative infection (Patients with mixed Grampositive or anaerobic infections may receive appropriate concomitant narrowspectrum antibiotics [eg, vancomycin, linezolid, metronidazole, clindamycin]).
- •3. Patients with coinfection caused by invasive aspergillosis, mucormycosis or other highly lethal mold.
- •4. Patients who have central nervous system infection (eg, meningitis, brain abscess, shunt infection).
- •5. Patients with infection requiring > 3 weeks of antibiotic treatment (eg, bone and joint infection, endocarditis).
- •6. Patients with cystic fibrosis or moderate to severe bronchiectasis.
- •7. Patients in refractory septic shock defined as persistent hypotension despite adequate fluid resuscitation or despite vasopressive therapy at the time of randomization.
- •8. Patients with severe neutropenia, ie, polymorphonuclear neutrophils (PMNs) < 100 cells/µL
- •9. Female patients who have a positive pregnancy test at Screening or who are lactating.
- •10. Patients with Acute Physiology and Chronic Health Evaluation II (APACHE II) score > 30.
- •11. Patients who have received a potentially effective antibiotic regimen for the carbapenem-resistant, Gram-negative infection for a continuous duration of more than 24 hours in cUTI, or 36 hours in HAP/VAP/HCAP or BSI/sepsis during the 72 hours leading to Randomization.
- •12. 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.
- •13. Patients who have received another investigational drug or device within 30 days prior to study entry.
- •14. Patients who have previously been randomized in this study or received S-649266.
- •15. Patients receiving peritoneal dialysis 16. Patients meeting specific exclusion criteria for each infection site (See Diagnosis-Specific Exclusion Criteria).
研究者
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