Invasive Pulmonary Aspergillosis Treatment Duration of Posaconazole-initiated Antifungal Strategy in Patients with Hematological Malignancies: a Prospective, Single-center Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- The duration of posaconazole-initiated antifungal treatment therapy for IPA in patients with hematological malignancies
研究概览
简要总结
The goal of this observational study is to identify the duration of posaconazole-initiated antifungal treatment for IPA in patients with hematological malignancies and to explore the value of monitoring immune factors and cells in IPA treatment in order to assess practices in IPA management in Chinese hematology patients including tools to evaluate duration and discontinuation. The main question it aims to answer is:
Does any indicators that could be used to guide the duration of IPA treatment? Does immune factors have value in monitoring IPA treatment? We will not do any interventions to participants. Participants will be monitored routinely for their clinical characteristics, microbiological test( including G/GM Test, Blood culture), Imaging examination, Blood routine, the number and function of immune cells, cytokines(IL-1β/IL-2/IL-4/IL-8/IL-10/IL-12/IL-17/IFN-α/IFN-γ/TNF-α)， and we will collect these datas for analysing.
详细描述
- A total of 15 patients will be involved in the study.
- For each patient, the investigator will first evaluate the patient to determine if the patient meets the enrollment criteria and does not meet any of the exclusion criteria.
- For the patients included in the study, the investigators will collect their blood RT, immune cell count and function, and cytokine levels (including IL-1β/IL-2/IL-4/IL-5/IL-6/IL-8/IL-10/IL-12/IL-17/INF-γ/INF-α/TNF-α et al).
- Closely monitor the patient's status and discontinue antifungal therapy if the patient meet the 4 critera: ①PMNs recovery>500；②previous signs/symptoms of active IPA (such as fever) has been resolved; ③nagative mycological evidence; ④CT: the reduction in the size of the lesion must exceed 90% or stable cave. If the patient does not meet any of these criteria, antifungal therapy is continued until the 4 critera are met.
- Blood RT, neutrophil count and function, and cytokine levels (IL-1β/IL-2/IL-4/IL-5/IL-6/IL-8/IL-10/IL-12/IL-17/INF-γ/INF-α/TNF-α) were collected at the time of stopping antifungal therapy and at 2, 4, 8, and 12 weeks after stopping treatment. At the same time, the patient's symptoms (cough, hemoptysis, fever, etc. )and signs (chest pain, etc. ) were observed and the patient's microbiology examination results (blood G/GM text, fungal culture, etc. ) and imaging examination results (CT, etc.) were collected at the follow-up.
- Follow-up will be conducted instantly if any symptom, sign, or text result suspected IPA after discontinuation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent form signed
- •Patient with hematological malignancies
- •Patients with posaconazole-initiated antifungal therapy
- •Treatment duration ≥12w
排除标准
- •Refuse to enroll
- •Pregnancy or breastfeeding women
- •Are expected to survive no more than 72 h
- •Fungal or mycobacterial lung co infection at time of IPA diagnosis
- •Hematological malignancy with lung location
- •Disseminated aspergillosis (lung and sinus aspergillosis can be included)
结局指标
主要结局
The duration of posaconazole-initiated antifungal treatment therapy for IPA in patients with hematological malignancies
时间窗: 12 weeks after discontinuation of posaconazole-initiated antifungal therapy
The primary outcome is the duration of posaconazole-initiated antifungal treatment therapy for IPA in patients with hematological malignancies
次要结局
- All-cause mortality on 2/4/8 /12 weeks after discontinuation(12 weeks after discontinuation of posaconazole-initiated antifungal therapy)
- IFI-free survival rate on 2/4/8/12 weeks after discontinuation(12 weeks after discontinuation of posaconazole-initiated antifungal therapy)
- Clinical success rate of posaconazole-initiated antifungal therapy(12 weeks after discontinuation of posaconazole-initiated antifungal therapy)
- The proportion of patients who restarted treatment after discontinuation(12 weeks after discontinuation of posaconazole-initiated antifungal therapy)
- Analysis of criteria that could be used to guide the discontinuation of IPA treatment(12 weeks after discontinuation of posaconazole-initiated antifungal therapy)
- The value of immune factors (IL-1β/IL-2/IL-4/IL-5/IL-6/IL-8/IL-10/IL-12/IL-17/IFN-α/IFN-γ/TNF-α) and cells (the count of neutrophil and lymphocytes)(from the beginning of posaconazole-initiated treatment to 12 weeks after discontinuation of posaconazole-initiated antifungal therapy)
- The trend of immune factors (IL-1β/IL-2/IL-4/IL-5/IL-6/IL-8/IL-10/IL-12/IL-17/IFN-α/IFN-γ/TNF-α) and cells (the count of neutrophil and lymphocytes)(from the beginning of posaconazole-initiated treatment to 12 weeks after discontinuation of posaconazole-initiated antifungal therapy)
研究者
Sun Yuqian
Principal Investigator
Peking University People's Hospital