EUCTR2008-000906-35-IT进行中（未招募）不适用
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of BAY 41-6551 as Adjunctive Therapy in Intubated and Mechanically-Ventilated Patients with Gram-Negative Pneumonia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 650
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. Males and non-pregnant, non-lactating females, 18 years of age or
- •older. For females of child-bearing potential, one of the following
- •medically acceptable contraceptive methods must be used: or they agree to abstain from heterosexual intercourse while participating in the
- •study. One or more of these methods should be used during the study and continue for 30 days after completion of the antibiotic therapy.
- •a) Double-barrier methods of contraception (eg, condoms plus
- •spermicidal foam)
- •b) Intrauterine contraceptive device
- •c) Approved pharmaceutical contraceptive product (eg, birth control pills or patches, long-term injectable or implantable hormonal
- •contraceptive)
- •2. Intubated and mechanically-ventilated (patients who have had a tracheotomy may be considered as possible study participants as long as they are being mechanically ventilated)
- •3. Diagnosis of pneumonia defined as presence of a new or progressive infiltrate(s) on chest radiograph
- •4. Presence of Gram-negative organism(s) indicated by:
- •a) Gram-stain OR
- •b) Culture of pre-therapy respiratory specimen (eg, acceptable TA, BAL,
- •mini-BAL, PSB)
- •5. At least two of the following: signs of infection:
- •a) Fever, defined as an oral temperature of > 38.0°C (100.4°F) or a
- •tympanic/ rectal/core temperature > 38.5°C (101.3°F), or hypothermia, defined as a tympanic/rectal/core body temperature of < 35.0°C (95.0°F)
- •b) Leukocyte count greater than or equal to 10,000/mm3 or less than or equal to 4,500/mm3, or an immature neutrophil (band) count > 15%
- •regardless of the peripheral leukocyte count
- •c) New onset of purulent sputum or respiratory secretions, or a change in the character of sputum
- •6. Impaired oxygenation as demonstrated by the following:
- •a) A decrease in PaO2/FiO2 by at least 50 mm Hg compared to a PaO2/FiO2 value within the last 48 hours from enrollment OR
- •b) PaO2/FiO2 value of < 240 mm Hg (not including adult respiratory distress syndrome [ARDS] patients) (the PaO2/FiO2 value used should be the value used when the CPIS was calculated)
- •7. CPIS greater than or equal to 6, (Section 15.3)
- •8. At least two risk factors for MDR organisms (MDR organism: an
- •organism resistant to representative agents in two or more of the
- •following antibiotic classes - beta-lactams, including penicillins,
- •cephalosporins, and monobactams; carbapenems; fluoroquinolones; and
- •aminoglycosides):
- •a) Antimicrobial therapy in the preceding two weeks
- •b) Current hospitalization greater than or equal to 5 days
- •c) High frequency (> 10%) of antibiotic resistance in the community or in the specific hospital unit
- •d) Immunosuppressive disease and/or therapy
- •e) Presence of the risk factors for HCAP
- •Hospitalization for two days or more in the preceding 90 days
- •Residence in a nursing home or extended care facility
- •Home infusion therapy (including antibiotics)
- •Chronic dialysis within 30 days
- •Home wound care
- •Family member with multidrug-resistant pathogen
- •9. Be willing and able to give written informed consent. If the patient is unable to give written informed consent, the patient's legally authorized representative (LAR) may provide written consent as approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
- •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 500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •1. A history of hypersensitivity to amikacin or other aminoglyosides,
- •2. Has received antibiotic therapy for Gram-negative pneumonia for greater than 24 hours at the time of study drug administration. (There
- •should be as minimal a time delay as possible between randomization
- •and first dose of study drug but up to 24 hours will be acceptable.
- •However, sites should still take into account that patients cannot receive more than 24 hours of prior antibiotic therapy for the current episode of Gram-negative pneumonia up to the time of study drug administration
- •[not to the time of randomization]).
- •Exceptions: Systemic antibiotic therapy for more than 24 hours in the 48 hours prior to enrollment is permitted in case the infection is caused by microbiologically-confirmed pathogens that are resistant to the
- •antimicrobial agent used to treat the current episode of Gram-negative
- •3. Has primary lung cancer (including patients with small cell lung carcinoma/non-small cell lung carcinoma and patients with unknown histology) or another malignancy metastatic to the lungs or other known endobronchial obstructions. Exception: Note that patients with complete
- •resection of non-small cell lung carcinoma are eligible for the study.
- •4. Known or suspected active tuberculosis, cystic fibrosis, human
- •immunodeficiency virus (HIV) infection with CD 4 count < 200 cell/mm3
- •(HIV testing is not required as part of this protocol), or invasive fungal infection of the lung, lung abscess, or empyema.
- •5. Known or suspected bacteremia secondary to Staphylococcus aureus
- •6. Known or suspected neuromuscular disorders such as myasthenia gravis or parkinsonism
- •7. Has had a stroke within five days. Additionally, patients with stroke should not be enrolled if at least one or both of the following apply:
- •a) There is an increased risk of fatal brain edema as indicated by a history of hypertension or heart failure, major early computed
- •tomography (CT) hypodensity exceeding 50% of the middle cerebral artery territory, and/or involvement of additional vascular territories.
- •b) There is indication for deterioration based on comparison of patient's neurological condition within six hours of planned study drug dosing and
- •patient's neurological condition two days before, judged by applying the National Institute of Health (NIH) Stoke Scale (Section 15.4).
- •8. A positive urine and /or serum beta-human chorionic gonadotropin (B-hCG) pregnancy test
- •9. Burns greater than 40% of total body surface area
- •10. Patients with a serum creatinine > 2 mg/dL (177 µmol/L)
- •Exception: Patients with a serum creatinine > 2 mg/dL (177 µmol/L) and being treated with continuous renal replacement therapy
- •(continuous veno-venous hemofiltration [CVVH] and continuous venovenous hemofiltration with dialysis [CVVH-D]) or daily hemodialysis will
- •receive the aerosol study drug treatment (Section 8.4.6.1).
- •11. Neutropenia (Screening absolute neutrophil count [ANC] < 103 neutrophils/mm3)
- •12. Has been on mechanical ventilation for > 28 days (ie, current event should not be more than 28 continuous days). A patient is not considered extubated if extubation lasts less than 24 hours.
- •13. Is participating in or has participated in other investigational
- •interventional studies within the previous 28 days
- •14. The risk of rapidly fatal illness and death within 72 hours, or any
- •concomitant conditions not related to VAP that, in the opinion of the investigator, precludes completion of study ev
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