EUCTR2021-004979-14-PT招募中1 期
A Phase 3, Randomized, Double-blind, Placebo-controlled, Single-dose Study to Evaluate the Efficacy and Safety of Suvratoxumab in Mechanically Ventilated Adults and Adolescents for the Prevention of Nosocomial Pneumonia - SAATELLITE-2
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 564
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Adult (18 [unless otherwise specified by local Country laws] to 65 years of age) or Adolescent (12 to < 18 years of age [unless otherwise specified by local Country laws]) at the time of screening.
- •2. Written informed consent and written informed assent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act [HIPPA] in the US, EU Data Privacy Directive in the EU) obtained from the subject/legally acceptable representative (LAR) prior to performing any protocol-related procedures, including screening evaluations.
- •3. Females of childbearing potential (inclusive of adolescents) who are sexually active with a non-sterilized male partner must have evidence of not being pregnant upon enrolment and have a negative pregnancy test prior to administration of investigational product.
- •- Females of childbearing potential are defined as those who are not surgically sterile (i.e., bilateral oophorectomy, or complete hysterectomy), premenarchal or postmenopausal (defined as 12 months with no menses without an alternative medical cause).
- •4. Tracheal or bronchial sample positive by polymerase chain reaction (PCR) for S. aureus within 36 hours prior to randomization. Note: the 36-hour window will be determined by the time of sample collection.
- •5. Currently intubated and on mechanical ventilation in the ICU.
- •6. Expected to remain intubated and mechanically ventilated for ¿ 3 days based on investigator estimate.
- •7. No diagnosis of new-onset pneumonia within 72 hours prior to randomization (subjects with evidence of resolved pneumonia will be eligible).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 14
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 550
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. The study subject is moribund or unlikely to survive for a week post randomization despite delivery of adequate antibiotics and supportive care, based on clinical judgement by the PI.
- •2. Acute confirmed or suspected active S. aureus disease at study enrolment and investigational product dosing (colonization is acceptable as per inclusion criterion #4).
- •3. Active pulmonary disease that would impair the ability to diagnose pneumonia, such as active tuberculosis or fungal disease, obstructing lung cancer, large empyema, cystic fibrosis, or acute respiratory distress syndrome with lung white out.
- •4. Receipt of anti- S. aureus systemic antibiotics for > 48 hours within 72 hours prior to randomization that are considered active against the S. aureus strain with which the subject is colonized, or anticipated ongoing receipt of anti- S. aureus systemic antibiotics.
- •5. APACHE-II score ¿ 25 (if Glasgow Coma Scale [GCS] score is > 5) or ¿ 30 (if GCS score is ¿ 5), or SOFA score ¿ 9 at time of randomization.
- •- Note: Vasopressors only used to improve cerebral perfusion pressure (e.g., subarachnoid hemorrhage) will not be entered in the calculation of the cardiovascular component of the SOFA score.
- •6. Receipt of any investigational drug therapy within 30 days prior to randomization.
- •7. Previous receipt of a mAb within 60 days prior to randomization.
- •8. Subjects with a CD4 count of < 200 due to advanced human immunodeficiency virus (HIV) infection. Subjects with a history of HIV infection who have been on highly active antiretroviral therapy and asymptomatic from HIV infection for at least 6 months may be enrolled.
- •9. History of allergic disease or reactions likely to be exacerbated by any component of the investigational product.
- •10. Not able to complete long-term follow-up for at least 90 days post dose based on investigator judgment.
- •11. Pregnant female or nursing mother.
研究者
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