EUCTR2010-023986-23-DE进行中（未招募）不适用
OASIS: A Phase 2/3 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients with Severe Sepsis - OASIS
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,280
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
- •1.Age 18 years
- •2.Onset of severe sepsis within the previous 24 hours as defined by meeting all of the following criteria (A, B and C). Organ dysfunction must be present at the time of randomization. Randomization must occur within 24 hours of the first documented organ dysfunction (C) as defined below (refer to Appendix F for the definitions of start time for each type of organ dysfunction):
- •A.Objective evidence of confirmed or suspected infection. Suspected infection must be based on objective clinical evidence such as: (a) neutrophils in a normally sterile body fluid; (b) perforated viscus; (c) radiographic evidence of pneumonia; or (d) a syndrome associated with a high likelihood of infection (e.g., ascending cholangitis), (e) evidence of an infecting organism such as pneumococcal antigen or Legionella antigen, and
- •B.the presence of at least three manifestations of the systemic inflammatory response syndrome (SIRS) due to infection (only two criteria if patient is on medication that controls heart rate or has a pacemaker) within 24 hours prior to start time of the first qualifying organ dysfunction or within 24 hours after the start time of the first qualifying organ dysfunction (see Inclusion Criterion 2C),:
- •Body temperature: i) hyperthermia as indicated by a temperature of =38º C (100.4º F); or ii) hypothermia as indicated by a core temperature =36º C (96.8º F). For defining hypothermia, temperature must be obtained via a rectal temperature, central venous catheter monitor, esophageal thermistor, or urinary bladder thermistor, not by oral tympanic or axillary measurement.
- •Heart rate =90/min
- •Respiratory rate =20/min or PaCO2 = 32 mmHg; or the use of mechanical ventilation for an acute respiratory process
- •WBC =12,000/mm3 or =4,000/mm3, or >10% immature neutrophils (i.e., bands) [Note: In the presence of granulocyte colony stimulating factor, for those patients whose WBC is > 12000 cells/
- •mm3 , the patient must have hyperthermia and at least one other criterion (HR or RR)]
- •C.at least one acute organ dysfunction due to sepsis, that is newly developed, and not explained by other disease processes or the effects of treatment and is ongoing at the time of randomization, defined as follows:
- •Septic shock (Cardiovascular) – the requirement for vasopressors,* despite adequate fluid resuscitation,** to maintain a MAP >65 mm Hg or a systolic pressure >90 mm Hg. (Note: for patients who develop cardiovascular dysfunction in the setting of intubation, this dysfunction must persist for = 1 hour post-intubation).
- •* Vasopressors are defined as dopamine =5 µg/kg/min or any dose of norepinephrine, epinephrine, phenylephrine, or vasopressin, with the intent to support blood pressure. Dobutamine and dopexamine are not considered vasopressors.
- •**Adequate fluid resuscitation is defined as one of the following: i) a minimum of a 20 mL/kg (ideal body weight) intravenous fluid challenge (crystalloid or equivalent colloid); 10 mL/kg of colloids = 20
- •mL/kg crystalloids) within a 6 hour period or a minimum of 30mL/kg crystalloid or equivalent colloid within 24 hours); or ii) if measured, a central venous pressure (CVP) =8 mm Hg or =12 mm Hg if mechanically ventilated; or iii) a pulmonary artery occlusion pressure (PAOP) =12 mm Hg or =16 mm Hg if mechanically ventilated.
- •Respiratory – must have mechanical ventilation and PaO2/FiO2 ratio =300 (SpO2/FiO2 =357) or if lung is the primary site of infection a PaO2/FiO2 ratio =200 (Sp
排除标准
- •1.Enrollment in an interventional experimental protocol involving an
- •investigational drug or a medical device within 60 days prior to
- •randomization or within 5 half-lives of the study drug, whichever is
- •longer. Co-enrollment in process of care trials or comparative trials of
- •approved products will be allowed if the protocol has been approved in
- •advance by the sponsor, as long as the co-enrollment does not violate
- •participation in the other protocol.
- •2.Severe congestive heart failure (e.g., NYHA Class IV or most recent known pre-sepsis ejection fraction <30%)
- •3.Neutrophils <1,000/mm3 unless due to sepsis
- •4.Known HIV infection with CD4 <200 cells/mm3 or illnesses associated with end stage AIDS (e.g., disseminated Mycobacterium Avium Complex, Cytomegalovirus and Progressive Multifocal Leukoencephalopathy)
- •5.Presence of 3rd-degree burns involving >20% body surface area (unless burn occurred >7 days prior to randomization)
- •6.Receiving significant immunosuppressants (see Appendix G, contact Clinical Coordinating Center for advice) or significant steroid dose (e.g., >20 mg prednisone or a steroid with equivalent activity), daily for > 2 weeks immediately prior to randomization.
- •7.Patient is moribund and whose death is considered imminent by the investigator
- •8.Life expectancy, due to pre-existing conditions such as cancer, is less than six months
- •9.Severe hypoxic encephalopathy (e.g., post cardiopulmonary resuscitation) or persistent vegetative state
- •10.Child-Pugh Class C liver disease pre-sepsis or known portal hypertension or esophageal varices
- •11.The patient or their legal representative, or the patient’s physician are not committed to providing full, aggressive life support, [a no CPR (chest compressions) in the setting of cardiac arrest” order is allowed]
- •12.Patients chronically bed-bound prior to the onset of sepsis
- •13.Pregnant or breast-feeding
- •14. Receiving polymyxin B hemoperfusion or planned use of polymyxin B hemoperfusion during the study
研究者
相似试验
进行中（未招募）
不适用
OASIS: A Phase 2/3 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients with Severe SepsisSevere SepsisMedDRA version: 14.1Level: PTClassification code 10040047Term: SepsisSystem Organ Class: 10021881 - Infections and infestationsEUCTR2010-023986-23-DKAgennix Incorporated1,280
进行中（未招募）
不适用
OASIS: A Phase 2/3 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients with Severe Sepsis - OASISSevere SepsisMedDRA version: 12.1Level: LLTClassification code 10040047Term: SepsisEUCTR2010-023986-23-GBAgennix Incorporated1,280
已完成
2 期
OASIS: A Phase 2/3 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients with Severe SepsisSevere sepsis10019815Septic shockNL-OMON35780Agennix Incorporated80
进行中（未招募）
不适用
OASIS: A Phase 2/3 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients with Severe SepsisSevere SepsisMedDRA version: 14.0Level: PTClassification code 10040047Term: SepsisSystem Organ Class: 10021881 - Infections and infestationsEUCTR2010-023986-23-BEAgennix Incorporated1,280
进行中（未招募）
不适用
OASIS: A Phase 2/3 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients with Severe SepsisSevere SepsisMedDRA version: 14.1Level: PTClassification code 10040047Term: SepsisSystem Organ Class: 10021881 - Infections and infestationsEUCTR2010-023986-23-NLAgennix Incorporated1,280