A Prospective Assessment of the Diagnostic Utility of Emerging Laboratory Assessments Used in Conjunction With FOB in HSCT and Leukemia Patients With Acute Respiratory Symptoms and Pulmonary Infiltrates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Number of Patients With Positive Culture or Molecular Results After Brochoscopy
研究概览
简要总结
Pulmonary infiltrates frequently complicate the care of hematopoietic stem cell transplant (HSCT) and leukemia patients. Bronchoalveolar lavage (BAL) is frequently used to evaluate new pulmonary infiltrates in this population, however utility is limited by a historically low diagnostic yield for infection.
In an effort to improve diagnostic yields, this study will complete a Fiberoptic Bronchoscopy (FOB) within 8 hours of radiographic documentation of pulmonary infiltrates, prior to initiating new antibiotic therapy. To further improve detection of microbiological pathogens, the study will utilize PCR testing with rapid turnaround time to detect atypical pneumonia (M pneumoniae, C. Pneumonia, Legionella species, and respiratory viruses) and aspergillosis.
详细描述
Proper diagnosis and prompt treatment favorably impacts survival in the post transplant setting, but is often difficult and frequently results in inappropriate or late therapy. Low yields may be linked with empiric antibody therapy begun prior to the procedure, delayed time to procedure, procedure technique, the presence of graft versus host disease (GVHD), neutropenia, and diffuse infiltrates (as opposed to localized infiltrates or focal masses and nodules). One recent study found that early FOBs (less than or equal to 4 days between detection of pulmonary infiltrates and FOB) were 2.5 times more likely to establish a diagnosis of pneumonia compared to late examinations. Delaying this procedure(greater than 5 days between detection of pulmonary infiltrates and FOB) was associated with drug resistant organisms, polymicrobial infections, and worsened patient prognosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Autologous or allogeneic stem cell patients with new acute respiratory symptoms or pulmonary infiltrates
- •leukemia patients with new acute respiratory symptoms or pulmonary infiltrates thought to be unrelated to disease
排除标准
- •Patients unwilling to undergo FOB
- •Patients unable to undergo FOB due to clinical status
- •Patients unable to undergo FOB within 8 hours of radiographic report of pneumonia
- •Patients unable to wait until completion of FOB to implement antibiotic changes
- •Adults unable to provide informed consent
结局指标
主要结局
Number of Patients With Positive Culture or Molecular Results After Brochoscopy
时间窗: 30 days
To determine the diagnostic yield related to fiberoptic bronchoscopy (FOB) with bronchoalveolar lavage (BAL) in hematopoietic stem cell transplant (HSCT) and leukemia patients with acute respiratory symptoms and pulmonary infiltrates utilizing both current standard of care microbiology testing and emerging molecular genetic laboratory assessments.
次要结局
- Number of Patients With Positive CT Result(30 days)
- Number of Participants With Positive Bacterial Results by PCR(24-48 hours)
- Number of Participants With Positive Viral Results by PCR(24-48 hours)
- Number of Participants With Positive Myocbacteria Results by Culture(24-48 hours)
- Number of Patients With Positive Fungal Results by PCR(24-48 hours)