Treatment Duration of IPA
NCT Number: NCT06583512
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Invasive Aspergillosis|Antifungal Therapy
Sponsor: Peking University People's Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-31
Completion Date: 2026-08-31

Summary:
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.

Primary Outcome Measures: The duration of posaconazole-initiated antifungal treatment therapy for IPA in patients with hematological malignancies, The primary outcome is the duration of posaconazole-initiated antifungal treatment therapy for IPA in patients with hematological malignancies, 12 weeks after discontinuation of posaconazole-initiated antifungal therapy
Secondary Outcome Measures: All-cause mortality on 2/4/8 /12 weeks after discontinuation, The mortality of patients died for any reasons on 2/4/8/12 weeks after discontinuation of antifungal therapy, 12 weeks after discontinuation of posaconazole-initiated antifungal therapy|IFI-free survival rate on 2/4/8/12 weeks after discontinuation, The IFI-free survival rate of patients on 2/4/8/12 weeks after discontinuation of antifungal therapy, 12 weeks after discontinuation of posaconazole-initiated antifungal therapy|Clinical success rate of posaconazole-initiated antifungal therapy, The rate of patients who achieved clinical remission after posaconazole-initiated antifungal therapy, 12 weeks after discontinuation of posaconazole-initiated antifungal therapy|The proportion of patients who restarted treatment after discontinuation, After discontinuation of posaconazole-initiated antifungal therapy ,the rate of patients who restarted treatment of antifungal, 12 weeks after discontinuation of posaconazole-initiated antifungal therapy|Analysis of criteria that could be used to guide the discontinuation of IPA treatment, After discontinuation of posaconazole-initiated antifungal therapy , the related therapy options will be analyzed and the investigators will do some recommmendations for 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), The blood RT、neutrophil function、lymphocyte count/function 、cytokine (IL-1β/IL-2/IL-4/IL-5/IL-6/IL-8/IL-10/IL-12/IL-17/IFN-α/IFN-γ/TNF-α) will be recorded and analysed at the beginning of the posaconazole-initiated treatment and 2/4/8/12 weeks after discontinuation of treatment., from the beginning of posaconazole-initiated treatment to 12 weeks after discontinuation of posaconazole-initiated antifungal therapy