IVIG for Acquired Immunodeficiency in Lung Transplant Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Number of Clinically Diagnosed Bacterial Infections During the Treatment Period
研究概览
简要总结
The purpose of this study is to determine if intravenous immunoglobulin (IVIG) can prevent bacterial infections in lung transplant patients with low serum levels of immunoglobulin.
详细描述
An increased risk of infection despite intensive antimicrobial prophylaxis is a well-recognized complication of lung transplantation. Recent evidence suggests that immunosuppressive therapy after solid organ transplantation may lead to humoral immunodeficiency due to hypogammaglobulinemia (HGG). In lung transplant recipients with HGG, IVIG therapy offers the potential to significantly decrease the incidence and severity of infections, thereby reducing morbidity and potentially mortality.
Comparison: The investigators are conducting a randomized clinical trial of IVIG versus placebo for lung transplant patients with severe HGG to see if IVIG decreases the number of bacterial infections in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lung transplant recipients > 3 months after transplant surgery
- •Immunoglobulin G (IgG) < 500 mg/dL
- •Stable medical regimen
排除标准
- •Acute rejection
- •Active infection
- •Contraindication to IVIG
- •Pregnancy
- •Recent thrombotic event
研究组 & 干预措施
First IVIG, then Placebo
Study participants will receive three doses of IVIG given four weeks apart over 12 weeks followed by a twelve-week washout and then three doses of placebo over 12 weeks.
干预措施: IVIG (Drug)
First IVIG, then Placebo
Study participants will receive three doses of IVIG given four weeks apart over 12 weeks followed by a twelve-week washout and then three doses of placebo over 12 weeks.
干预措施: Placebo (Other)
First Placebo, then IVIG
Study participants will receive three doses of 0.1% albumin solution (placebo) given four weeks apart over 12 weeks followed by a twelve-week washout and then three doses of IVIG over 12 weeks.
干预措施: IVIG (Drug)
First Placebo, then IVIG
Study participants will receive three doses of 0.1% albumin solution (placebo) given four weeks apart over 12 weeks followed by a twelve-week washout and then three doses of IVIG over 12 weeks.
干预措施: Placebo (Other)
结局指标
主要结局
Number of Clinically Diagnosed Bacterial Infections During the Treatment Period
时间窗: 3 month
The number of events occurring during the treatment period. The data will be presented by the occurrence during the IVIG vs. the placebo treatment period, regardless of the order that the treatment was received. Only the clinically diagnosed bacterial infections will be counted.
次要结局
- Number of Clinically Diagnosed Viral Infections(3 month)
- Number of Antibiotic Initiation(3 month)
- Number of Hospital Admissions(3 month)
- Number of Clinically Diagnosed Fungal Infection(3 months)
- Number of Lymphocytic Bronchiolitis(3 months)
研究者
Selim Arcasoy
Dickinson W. Richards, Jr. Professor of Medicine (in Pediatrics) at the Columbia University Medical Center, Dept of Medicine Pulmonary
Columbia University