EUCTR2016-004261-10-GR进行中（未招募）1 期
Placebo-controlled, double-blind, randomized study of Aerucin® as adjunct therapy to antibiotics in the treatment of P. aeruginosa pneumonia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 154
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 authorized 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.
- •Taiwan only: To be at least 20 years of age.
- •South Korea only: To be at least 19 years of age
- •3. To be treated in an ICU at the time of enrollment.
- •4. Endotracheal tube in place (tracheostomy is allowed).
- •5. The patient is mechanically ventilated.
- •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, or
- •A sequence of at least 2 chest X-rays showing the presence of new or
- •progressive infiltrate(s) suggestive of bacterial pneumonia.
- •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 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 or
- •iii. Respiratory failure necessitating intubation and mechanical
- •ventilation. If tracheostomy is in place, the need for mechanical
- •ventilation.
- •c. At least one of the following signs:
- •i. Documented fever (e.g., body temperature greater than or equal to 38º
- •ii. Hypothermia (e.g., core body temperature less than or equal to 35º
- •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
- •v. Greater than 15 percent immature neutrophils (bands) noted on
- •peripheral blood smear.
- •7. Documented pulmonary infection with P. aeruginosa obtained by BAL,
- •mini-BAL, protected endotracheal tube aspiration (ETA) (collectively
- •'airway specimen'). For the study randomization, P. aeruginosa must be
- •identified by one of the three methods below:
- •a. An airway specimen culture positive by any method for P. aeruginosa
- •of a specimen obtained less than 72 hours prior to randomization. A
- •fresh airway specimen must be obtained prior to treatment initiation for
- •baseline standard microbial culture by the local laboratory (including
- •organism identification, quantitative/semi-quantitative culture and
- •susceptibility testing); the corresponding culture results are NOT
- •required prior to randomization.
- •b. A rapid diagnostic test. In such ca
排除标准
- •1. The subject is moribund. Clinical judgment by the investigator that the
- •subject is unlikely to survive the current illness/ICUadmission/treatment period despite delivery of adequate antibiotics for
- •treatment of P. aeruginosa pneumonia.
- •2. Effective antibacterial drug therapy for the index pneumonia
- •administered continuously for 48 hours or more prior to initiation of
- •study treatment. Effective antibiotics would include those typically used
- •to treat P. aeruginosa.
- •3. Plasmapheresis (ongoing or planned) or any procedure that would
- •remove/filter out the monoclonal antibody/study drug.
- •4. Immunocompromised and at risk of infection by opportunistic
- •pathogens including, 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. Heart or lung transplant recipient within the past 6 months.
- •5. Known hereditary complement deficiency.
- •6. Liver dysfunction with a Child Pugh C score (Child Pugh score of A or B
- •are acceptable at discretion of the 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).
- •8. Patient has received IV immunoglobulin therapy within 3 months prior
- •to the Screening Visit.
- •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. Non-pregnant and
- •non-lactating with confirmation via local laboratory testing is required.
- •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 to 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.
研究者
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