EUCTR2007-000442-12-GR进行中（未招募）不适用
A non-comparative open pilot trial to assess the safety and pharmacokinetics of up to three single doses of AERUMAB 11 in patients with ventilator associated pneumonia caused by serotype O11 P. aeruginosa - AERUMAB 11
Kenta Biotech Ltd0 个研究点目标入组 40 人开始时间: 2008年11月4日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
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. Male or female = 18 years of age
- •2. Female patients sterilised, hysterectomised, post-menopausal, or negative pregnancy test at screening evaluation
- •3. Patient mechanically ventilated for at least 48 hours and clinical diagnosis (including a new or progressive infiltrate) of ventilator associated pneumonia (VAP), including recurrent VAP, with modified clinical pulmonary infection score (CPIS) higher than 3 points
- •4. Greater of equal to 6x105 CFU/mL of P. aeruginosa in quantification of mini-BAL tested with Roche-PCR-kit,and confirmed diagnosis of P. aeruginosa serotype O11 VAP tested in mini-BAL with Kenta-PCR-Kit
- •microbiologically confirmed diagnosis of P. aeruginosa serotype O11 VAP tested in miniBAL or BAL with conventional microbiology (equal or greater to 1x104 CFU/mL)
- •5. Patient is expected to survive longer than 72 hours
- •6. Written informed consent provided by relatives or the designated trusted person
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Use of any investigational drug within 30 days preceding the first dose of AERUMAB 11, or planned use during the study and safety follow-up periods
- •2. Existence of any surgical or medical condition that might render the patient unduly susceptible to possible toxicity from the monoclonal antibody, including septic shock
- •(defined as hypotension, i.e. a systolic blood pressure < 90 mmHg, or a MAP < 60 mmHg, or a reduction of 40 mmHg in the systolic blood pressure from baseline,
- •despite adequate fluid resuscitation) with or without multiple organ dysfunction syndrome (MODS), and presence of clinically relevant disseminated intravascular
- •coagulation (overt DIC, as defined by a score of 5 or more using the scoring system proposed by the Scientific Subcommittee on Disseminated Intravascular Coagulation (DIC) of the ISTH) 3. Patients with a known hereditary complement deficiency
- •associated with systemic lupus erythematosus (SLE), paroxysmal nocturnal hemoglobinuria (PNH), hereditary angioedema (HAE), membranoproliferative
- •glomerulonephritis, collagen vascular disease, autoimmune hepatitis, primary biliary cirrhosis, scleroderma, or recurrent Neisserial infections
- •4. Confirmed Human Immunodeficiency Virus (HIV) infection
- •5. Transplant patients and/or sSimultaneous treatment with systemic immuno-suppressive drugs (prednisone or prednisolone allowed)
- •6. Patients with a known liver function deficiency, e.g. associated with liver cirrhosis (Child Pugh B or C) or acute hepatitis
- •7. Administration of poly- or mono-immunoglobulins within the three months preceding the first dose of study drug or planned administration during the study period
- •8. Neutropenic patients (absolute neutrophil count < 1000 cells per microlitre)
研究者
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