EUCTR2017-004339-35-FR进行中（未招募）1 期
A Randomized double-blind placebo-controlled multicenter Phase 3 study of efficacy and safety of AR-301 as adjunct therapy to antibiotics in the treatment of Ventilator-Associated Pneumonia (VAP) caused by S. aureus
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
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
入选标准
- •1. Written Informed Consent given by the patient or, if not possible, by a legally acceptable representative and/or an independent physician as authorized by the competent ethics committee (EC) or independent review board (IRB) and local regulations.
- •2. To be at least 18 years of age.
- •For Taiwan: To be at least 20 years of age.
- •For South Korea: To be at least 19 years of age.
- •3. Treated in an ICU at the time of enrollment.
- •4. Endotracheal tube in place (tracheostomy is allowed),
- •5. The patient is mechanically ventilated for at least 48 hours.
- •6. Diagnosis of pneumonia based on the following criteria (a, b, and c, all must be met):
- •a. One definitive chest X-ray diagnostic of pneumonia within 48 hours.
- •b. Hypoxemia based on at least one of the following measurements criteria:
- •i. PaO2/FiO2 < 250 mmHg (at sea level or equivalent for significant elevations above sea level) while intubated and mechanically ventilated, as one or more measures within = 48 hours prior to randomization, or
- •ii. PaO2 < 60 mmHg (at sea level or equivalent for significant elevations above sea level) while intubated and mechanically ventilated, as one or more measures within = 48 hours prior to randomization.
- •c. At least one of the following signs:
- •i. Documented fever (e.g., body temperature greater than or equal to 38º Celsius).
- •ii. Hypothermia (e.g., core body temperature less than or equal to 35º Celsius).
- •iii. Total peripheral white blood cell (WBC) count greater than or equal to 10,000 cells/µL (or mm3).
- •iv. Leukopenia with total WBC less than or equal to 4,500 cells/µL (mm3).
- •v. Greater than 15 percent immature neutrophils (bands) noted on peripheral blood smear.
- •7. Documented pulmonary infection with S. aureus obtained by BAL, mini-BAL, ETA (collectively ‘airway specimen’). More than one pathogen allowed, if S. aureus is regarded as a pneumonia causing pathogen requiring S. aureus targeting antibiotic therapy.
- •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 160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •1. The subject is unlikely to survive for the study duration despite delivery of adequate antibiotics and supportive care for treatment of S. aureus pneumonia.
- •2. Effective antibacterial drug therapy for the index pneumonia administered continuously for more than 72 hours prior to initiation of study treatment. Effective antibiotics include intravenous (IV) and/or oral medications typically used to treat S. aureus.
- •3. Plasmapheresis (ongoing or planned), extracorporeal membrane oxygenation (ECMO) or any procedure that would remove/filter out the monoclonal antibody (mAb)/study drug.
- •4. Immunocompromised patients due to, but not limited to the following:
- •a. HIV / AIDS who are not stable under medication and/or most recent CD4 < 200
- •b. Expected neutropenia due to chemotherapy
- •c. Absolute neutrophil count less than 500/µL (mm3)
- •d. Organ transplant requiring systemic immunosuppressive therapy within the past 6 months.
- •e. Chronic administration of systemic corticosteroids, defined as > 40 mg of prednisone or
- •equivalent per day administered within 14 days prior to the first dose of study drug.
- •5. Known hereditary complement deficiency.
- •6. Liver dysfunction with a Child Pugh C score > 9 (Child Pugh score of A or B are acceptable at discretion of the Principal Investigator [PI]).
- •7. Pulmonary disease that precludes evaluation of a therapeutic response (such as lung cancer resulting in bronchial obstruction or on the same side as the pneumonia, active tuberculosis, cystic fibrosis, granulomatous disease, fungal pulmonary infection, lung abscess, pleural empyema or post obstructive pneumonia). Chronic obstructive pulmonary disease (COPD) is not
- •an exclusion criterion.
- •8. Patient has received IV immunoglobulin therapy within 3 months prior to the Screening
- •9. Any woman of child-bearing potential (WOCBP) who does not have a negative pregnancy test result at Screening using SERUM or URINE testing based on Beta-subunit human chorionic gonadotropin (HCG) standard tests and methods from the local laboratory. Nonpregnant with confirmation via local laboratory testing is required. Lactating women are also excluded. Women who are post-menopausal as evidenced by the absence of menstruation for at least 1 year are eligible; the date of last menstruation is to be recorded in the study files unless post-menopausal status is obvious due to age.
- •10. Any sexually active subject who is unwilling to use acceptable methods of contraception for 120 days after dosing. WOCBP must agree to use an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, barrier methods, abstinence) or male partner sterilization alone for the duration of the study and for at least 120 days after dosing. Males with female partners of reproductive potential must agree to practice abstinence or to use a condom (male) plus an additional barrier method (female partner) of contraception for the duration of the study and for at least
- •120 days after dosing.
- •11. Known lack of treatment compliance from prior studies or ongoing medical care based on medical records and Prin
研究者
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