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Treatment Duration of IPA

NCT ID: NCT06583512

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-01

Study Completion Date

2026-08-31

Brief Summary

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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

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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.

Conditions

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Invasive Aspergillosis Antifungal Therapy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sun Yuqian

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yuqian Sun

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

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Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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2024PHB035-001

Identifier Type: -

Identifier Source: org_study_id