EUCTR2021-003273-66-IT招募中1 期
A Phase 2, Multi-Center, Randomized, Placebo-Controlled, Dose-Finding Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients - Efficacy and safety of Allocetra-OTS in patients with sepsis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 160
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
- •1. Male or female =18 years and =90 years of age.
- •2. Meets Sepsis 3 criteria: the presence of organ dysfunction as identified by a total SOFA score =2 points above pre-admission SOFA. Patients in septic shock with SOFA score up to 9 may be included.
- •3. Initiation of antibiotics treatment for the suspected infection.
- •4. Sepsis due to infection in at least one of the below organs:
- •4.1. Suspected, presumed or documented Community-Acquired Pneumonia (CAP).
- •4.2 Urinary tract infection
- •4.3. Acute cholecystitis
- •4.4. Acute cholangitis
- •4.5. Other Intra-Abdominal Infections (IAI)
- •5. Adequate source control if necessary as determined by the investigator, or source control is scheduled to be completed prior to IP administration. In case source control will not be completed prior to IP administration, Sponsor pre-approval is
- •required for IP administration.
- •6. Signed written informed consent by the patient, or consent obtained according to local regulations if the patient is unable to provide informed consent.
- •7. Women of childbearing potential and all men must agree to use 2 methods of an adequate contraception: One barrier method (e.g. diaphragm, or condom or sponge, each of which are to be combined with a spermicide) and one hormonal method (e.g. oral, transdermal patch, implanted contraceptives or intrauterine device) prior to study entry and for the duration of study participation through 4 weeks following IP administration. Subjects that are highly unlikely to conceive (e.g. surgically sterile, postmenopausal, or not heterosexually active) are exempt.
- •Non-childbearing potential is defined as (by other than medical reasons):
- •=45 years of age and has not had menses for over 2 years.
- •<45 years of age and amenorrhoeic for > 2 years without a hysterectomy and oophorectomy and a Follicle Stimulating Hormone (FSH) value in the postmenopausal range upon pre-trial (screening) evaluation.
- •For women, post hysterectomy, bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation and vasectomy for men at least 6 weeks prior to screening. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure.
- •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 67
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 93
排除标准
- •1. Sepsis due to infection other than lung infection, UTI or IAI, or sepsis patients where site of infection is unclear or unknown.
- •2. On chronic dialysis.
- •3. Patients with acute pancreatitis (serum amylase > 3 ULN with clinical abdominal pain).
- •4. Invasive ventilated patient and PaO2/FiO2 < 100 mmHg.
- •5. Weight <50 kg or >120 kg or Body Mass Index (BMI) >40 kg/m2.
- •6. SOFA score = 10 at screening (Day -2 to -1).
- •7. Patients with risk of nosocomial infection due to hospitalization or surgery within 30 days prior to diagnosis of sepsis.
- •8. A known malignancy that is progressing or has required active treatment within the past 3 months.
- •9. Patient with end-stage disease (unrelated to sepsis) defined as patients who prior to the current hospitalization are expected to live < 6 months (as assessed by the study physician).
- •10. Known active symptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or chronic viral infections, such as, hepatitis B virus (HBV) or hepatitis C virus (HCV), human immunodeficiency virus (HIV) or other chronic infections.
- •11. Chronic respiratory disease requiring home oxygen therapy on a regular basis for > 6 h/day.
- •12. Known active upper gastrointestinal (GI) tract ulceration or hepatic dysfunction including but not limited to biopsy-proven cirrhosis; End-stage cirrhosis (Child Pugh Class C); portal hypertension; episodes of past upper GI bleeding attributed to portal hypertension; or prior episodes of hepatic failure, encephalopathy, or coma.
- •13. Known New York Heart Association (NYHA) class IV heart failure or unstable angina, ventricular arrhythmias, acute coronary disease, or myocardial infarction within six months prior to diagnosis of sepsis.
- •14. Known immunocompromised state or medications known to be immunosuppressive as follows:
- •Hydrocortisone (for the treatment of septic shock) > 300 mg /d Prednisone or equivalent to a dose =10 mg/day, for more than 14 days within the last 28 days.
- •Methotrexate, cyclophosphamide, cyclosporine A (unless as ophthalmic formulation), leflunomide/teriflunomide (unless as monotherapy), tacrolimus (unless as a topical formulation), sirolimus, everolimus, temsirolimus, mycophenolate mofetil or azathioprine, in the last 60 days;
- •Chemotherapy in the last 3 months;
- •Mycophenolate mofetil (MMF) or sirolimus for solid organ transplant or bone marrow transplant with no time limitation.
- •Thalidomide within the last 72 hours.
- •Anti-tumor necrosis factor (TNF) agents, interleukin (IL)-1 receptor antagonists (IL-1-RA), CTLA-4 fusion proteins, anti-CD20, anti-CD52, anti-IL-2, anti-IL-6R, anti-IL-12/23, anti-B-cell activation factor (BAFF) or integrin inhibitor agents within the last 8 weeks.
- •15. Organ allograft or previous history of stem cell transplantation.
- •16. Women who are pregnant or breastfeeding. Child-bearing potential females must have a negative serum ß-hCG or hCG blood test at screening. Pregnancy testing is not required for postmenopausal or surgically sterilized women.
- •17. Known hypersensitivity to any component of study treatment or excipients.
- •18. Participation in an interventional investigational study within 30 days prior to diagnosis of sepsis.
- •19. Likely to be non-compliant or uncooperative during the study (e.g. substance abuse such as drug or alcohol abuse, uncontrolled psychiatric disorder or any chronic condition that may interfere with study conduct).
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