Randomized Double-blind Placebo-controlled Prevention Trial of Azithromycin in Lung Transplantation.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Prevalence of Bronchiolitis Obliterans Syndrome (BOS)
研究概览
简要总结
Preventive treatment with azithromycin reduces the prevalence fo Bronchiolitis Obliterans Syndrome after lung transplantation.
详细描述
- Prospective, interventional, randomized, double-blind, placebo-controlled trial.
- Clinical setting (tertiary University Hospital).
- Investigator-driven, no pharmaceutical sponsor.
- Lung transplant recipients.
- Add-on of study-drug (placebo or azithromycin) to 'standard of care' (standardized, routine immunosuppressive and infectious prophylactic protocol).
- 1:1 inclusion ratio (placebo:azithromycin).
- Randomisation at discharge after informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable LTx recipients at discharge after transplantation.
- •Signed informed consent
- •Adult (age at least 18 years old at moment of transplantation)
- •Able to take oral medication
排除标准
- •Prolonged and/or complicated ICU-course after transplantation.
- •Early (<30 days post-transplant) post-operative death
- •Major suture problems (airway stenosis or stent)
- •Retransplantation (lung)
- •Previous transplantation (solid organ)
- •Multi-organ transplantation (lung+ other solid organ)
研究组 & 干预措施
Azithromycin
250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
干预措施: Azithromycin (Drug)
Placebo
PLacebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
干预措施: Placebo (Drug)
结局指标
主要结局
Prevalence of Bronchiolitis Obliterans Syndrome (BOS)
时间窗: 2 years post-transplant
BOS was defined as a sustained decrease in forced Expiratory Volume in one second (FEV1) of at least 20% from the patient's maximum post-operative values in the absence of other causes.
Overall Survival
时间窗: 2 years post-transplant
Survival data were obtained using all-cause mortality information in the Leuven University Hospital transplant database, in which all our lung transplant recipients since 1991 are registered. For the end-point of all-cause mortality, survival times were not censored at retransplantation or at study-discontinuation if these preceded death, or else at 2 years after transplantation.
次要结局
- Acute Rejection Incidence Rate(2 years post-transplant)
- Infection Incidence Rate(2 years post-transplant)
- Pulmonary Function(during first two years post-transplant)
- Broncho-alveolar (BAL) Neutrophilia(during first two years post-transplant)
- Plasma C-reactive Protein (CRP) Levels(during the first two years post-transplant)