EUCTR2016-002146-23-HU进行中（未招募）1 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Safety and Efficacy of a Single Dose of ASN100 for the Prevention of Staphylococcus aureus Pneumonia in Heavily Colonized, Mechanically Ventilated Subjects
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 354
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.Subject or legally authorized representative (LAR) or CIP (if applicable) has provided written informed consent;
- •2.Subject is 18 years of age or older at the time of enrollment;
- •3.Subject is currently hospitalized and is mechanically ventilated endotracheally (i.e., orotracheal or nasotracheal) and, in the Investigator’s opinion, will require ongoing ventilator support for at least 48 hours;
- •NOTE: Subjects with a tracheostomy at the time of enrollment are not eligible. After enrollment, conversion to tracheostomy is permitted per standard of care.
- •4.Female subjects must not be pregnant or lactating. Female subjects of childbearing potential must have a documented negative pregnancy test at the Screening Visit. Female subjects may be enrolled on the basis of a negative urine pregnancy test, pending the result of a negative serum pregnancy test prior to randomization; and
- •5.Female subjects of childbearing potential and non-surgically sterile male subjects who are sexually active must agree to use an approved highly effective form of contraception from the time of informed consent until 165 days post dose. Approved forms of contraception include hormonal intrauterine devices (IUD), hormonal contraceptives (oral birth control pill, depot, patch or injectable) together with supplementary double barrier methods such as condoms or diaphragms with spermicidal gel or foam.
- •NOTE: The following categories define women who are NOT considered to be of childbearing potential:
- •Premenopausal female with 1 of the following:
- •o Documented hysterectomy,
- •o Documented bilateral salpingectomy, or
- •o Documented bilateral oophorectomy, or
- •Postmenopausal female, defined as having amenorrhea for at least 12 months without an alternative medical cause.
- •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 254
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1.Subject has received intravenous (IV) immunoglobulin therapy within 4 months prior to the Screening Visit;
- •2.Subject has a chest X-ray or thoracic CT scan that is definitive for a diagnosis of pneumonia;
- •3.Subject demonstrates both of the following:
- •a.Need for acute changes in ventilator support to enhance oxygenation or to the amount of positive end-expiratory pressure; and
- •NOTE: Changes made in ventilator support due to day to day maintenance other than those changes made to improve oxygenation will not exclude a subject from participation in the study.
- •b.New onset of purulent suctioned respiratory secretions;
- •4.Subject has a known and documented ETA culture showing heavy colonization with a Gram negative organism at enrollment or at any time during the Screening period;
- •NOTE: Randomization should not be delayed while waiting for Gram-negative results if heavy colonization with S. aureus has been confirmed.
- •5.Subject has been diagnosed with neutropenia (absolute neutrophil count 500/mm3);
- •6.Subject has a severe non-pulmonary source of infection which, in the Investigator’s opinion, would interfere with the conduct of the study or jeopardize the subject’s safety;
- •7.Subject is currently on either continuous veno- venous hemodialysis or extracorporeal membrane oxygenation;
- •8.Subject has been previously exposed to ASN100 or ASN-1 or ASN-2, individually;
- •9.Subject has a known hypersensitivity to ASN100 or any of its excipients;
- •10.Subject has received any investigational product within 30 days prior to the Screening Visit (or 5 half-lives of the investigational product, whichever is longer);
- •11.Subject has, in the opinion of the Investigator, a high probability of death within 72 hours of enrollment;
- •12. Subject is, in the opinion of the Investigator, not able or willing to comply with the protocol;
- •13. Any condition that, in the opinion of the Investigator, would compromise the safety of the subject, the potential activity of the study drug, or the quality of the data; or
- •14. Subjects with a known history or current (suspected) diagnosis of cytokine release syndrome associated with the administration of peptides, proteins, and/or antibodies.
- •NOTE: Subjects with a prior history of sepsis are not excluded.
研究者
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