EUCTR2015-003510-25-DE进行中（未招募）1 期
A Phase I-II Study of the Safety and Efficacy of a True Human Antibody, 514G3, in Subjects Hospitalized with Bacteremia Due to Staphylococcus Aureus
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 52
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
- •No waivers/exemptions will be granted for protocol inclusion/exclusion criteria.
- •Subjects are included in the study if they meet all of the following criteria:
- •1.One or more blood cultures positive for staphylococcus aureus within 2 days of randomization. Note that the 2-day clock begins when the culture is determined to be positive for staphylococcus aureus, and not when the culture was drawn.
- •2.Age =18, male or female subjects.
- •3.Adequate renal function, defined by serum creatinine = 2 times the upper limit of normal (ULN). However, subjects with chronic renal insufficiency that are receiving dialysis are eligible even with a serum creatinine >2 times the upper limit of normal.
- •4.Adequate hepatic function defined as:
- •?Total bilirubin = 3 times the ULN.
- •?Alanine aminotransferase (ALT) = 10 times the ULN.
- •5.Adequate bone marrow function as defined as:
- •?Absolute neutrophil count (neutrophil and bands) of ? 1,500/mm3 (? 1.5 x 109/L)
- •?Platelet count ? 100,000/mm3
- •6.For women of childbearing potential (WOCBP), a negative serum pregnancy test result at Screening.
- •7.Signed and dated institutional review board (IRB)/ Ethics Committee (EC)-approved informed consent before any protocol-specific screening procedures are performed. If the subject is unable to sign, the LAR may sign as their representative.
- •8.Expected survival unrelated to the staphylococcal bacteremia of at least 2 months.
- •9.If the patient has a central venous catheter in place at the time of qualifying blood culture, and the bacteremia is thought to be secondary to the catheter, the subject and his/her primary health care provider must agree to having the catheter removed within 5 days of randomization
- •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 52
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 52
排除标准
- •Subjects with ANY of the following will be excluded from the study:
- •1. Polymicrobial bacteremia.
- •2. Known or suspected complicated bacteremia:
- •a. Meningitis
- •b. Brain abscess
- •c. Epidural abscess
- •d. Intracranial hemorrhage due to mycotic aneurysm
- •e. Definite Left Sided Endocarditis as defined by modified Duke criteria (Right-sided endocarditis is allowed):
- •f. Visceral abscess (Liver,Spleen, Kidney)
- •g. Staphylococcal Pneumonia (any one criteria below)
- •i. Pulmonary infiltrate consistent with pneumonia
- •ii. S aureus recovered from pleural fluid or bronchoalveolar lavage
- •iii. Clinical evidence of pneumonia (increased FiO2, elevated respiratory rate, cough, purulent sputum)
- •h. Pyomyositis
- •i. Septic arthritis
- •j. Septic thrombophlebitis
- •3. Need for emergent valve surgery at the time of screening, and/or the presence of decompensated heart failure or cardiogenic shock.
- •4. History of HIV Infection with a nadir CD4+ count of <200 cells/mm3 upon the most recent measurement
- •5. Subjects with history of hypersensitivity to compounds of similar chemical or biologic composition to 514G3 or any component of its formulations.
- •6. Women who are pregnant or breastfeeding.
- •7. Non-removable intravascular foreign material in-situ when the qualifying blood culture was performed (eg cardiac pacemaker, defibrillator, prosthetic heart valve). Extravascular prostheses (prosthetic joints, surgical mesh, orthopedic pins/plates) are allowed as long as there is no evidence of infection at the site at the time of enrollment.
- •8. Presence of septic shock during or prior to screening. Septic shock is defined as sepsis-induced hypotension persisting despite adequate fluid resuscitation
- •9. Investigational agent in past 30 days
研究者
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