Clinical trial NCT06583512: Treatment Duration of IPA
Official title: Invasive Pulmonary Aspergillosis Treatment Duration of Posaconazole-initiated Antifungal Strategy in Patients with Hematological Malignancies: a Prospective, Single-center Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Invasive Aspergillosis
Antifungal Therapy
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2024-09-04
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: These patients had a hematological malignancies, and then had a invasive pulmonary aspergillosis. They were treated by posaconazole as their initiated drug and the treatment duration last for more than 12 weeks.

Brief 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.

Detailed description: 1. A total of 15 patients will be involved in the study.
2. 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.
3. 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).
4. 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.
5. 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.
6. Follow-up will be conducted instantly if any symptom, sign, or text result suspected IPA after discontinuation.

Eligibility criteria: Inclusion Criteria:

1. Informed consent form signed
2. Patient with hematological malignancies
3. Patients with posaconazole-initiated antifungal therapy
4. Treatment duration ≥12w

Exclusion Criteria:

1. Refuse to enroll
2. Pregnancy or breastfeeding women
3. Are expected to survive no more than 72 h
4. Fungal or mycobacterial lung co infection at time of IPA diagnosis
5. Hematological malignancy with lung location
6. Disseminated aspergillosis (lung and sinus aspergillosis can be included)

Primary outcomes:
measure: The duration of posaconazole-initiated antifungal treatment therapy for IPA in patients with hematological malignancies
timeFrame: 12 weeks after discontinuation of posaconazole-initiated antifungal therapy
Secondary outcomes:
measure: All-cause mortality on 2/4/8 /12 weeks after discontinuation
timeFrame: 12 weeks after discontinuation of posaconazole-initiated antifungal therapy
measure: IFI-free survival rate on 2/4/8/12 weeks after discontinuation
timeFrame: 12 weeks after discontinuation of posaconazole-initiated antifungal therapy
measure: Clinical success rate of posaconazole-initiated antifungal therapy
timeFrame: 12 weeks after discontinuation of posaconazole-initiated antifungal therapy
measure: The proportion of patients who restarted treatment after discontinuation
timeFrame: 12 weeks after discontinuation of posaconazole-initiated antifungal therapy
measure: Analysis of criteria that could be used to guide the discontinuation of IPA treatment
timeFrame: 12 weeks after discontinuation of posaconazole-initiated antifungal therapy
measure: 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)
timeFrame: from the beginning of posaconazole-initiated treatment to 12 weeks after discontinuation of posaconazole-initiated antifungal therapy
measure: 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)
timeFrame: from the beginning of posaconazole-initiated treatment to 12 weeks after discontinuation of posaconazole-initiated antifungal therapy
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People&#39;s Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Yuqian Sun
role: PRINCIPAL_INVESTIGATOR
References: