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Active, Not Recruiting

NCT Number: NCT06583512

Treatment Duration of IPA

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Invasive Aspergillosis Antifungal Therapy

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed consent form signed
  • Patient with hematological malignancies
  • Patients with posaconazole-initiated antifungal therapy
  • Treatment duration ≥12w

Exclusion criteria

  • 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)

Treatment and study plan

Primary outcomes

  1. The duration of posaconazole-initiated antifungal treatment therapy for IPA in patients with hematological malignancies

    Time frame: 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

Secondary outcomes

  1. All-cause mortality on 2/4/8 /12 weeks after discontinuation

    Time frame: 12 weeks after discontinuation of posaconazole-initiated antifungal therapy

    The mortality of patients died for any reasons on 2/4/8/12 weeks after discontinuation of antifungal therapy

  2. IFI-free survival rate on 2/4/8/12 weeks after discontinuation

    Time frame: 12 weeks after discontinuation of posaconazole-initiated antifungal therapy

    The IFI-free survival rate of patients on 2/4/8/12 weeks after discontinuation of antifungal therapy

  3. Clinical success rate of posaconazole-initiated antifungal therapy

    Time frame: 12 weeks after discontinuation of posaconazole-initiated antifungal therapy

    The rate of patients who achieved clinical remission after posaconazole-initiated antifungal therapy

  4. The proportion of patients who restarted treatment after discontinuation

    Time frame: 12 weeks after discontinuation of posaconazole-initiated antifungal therapy

    After discontinuation of posaconazole-initiated antifungal therapy ,the rate of patients who restarted treatment of antifungal

  5. Analysis of criteria that could be used to guide the discontinuation of IPA treatment

    Time frame: 12 weeks after discontinuation of posaconazole-initiated antifungal therapy

    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.

  6. 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)

    Time frame: from the beginning of posaconazole-initiated treatment to 12 weeks after discontinuation of posaconazole-initiated antifungal therapy

    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.

  7. 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)

    Time frame: from the beginning of posaconazole-initiated treatment to 12 weeks after discontinuation of posaconazole-initiated antifungal therapy

    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.

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

Invasive Pulmonary Aspergillosis Treatment Duration of Posaconazole-initiated Antifungal Strategy in Patients with Hematological Malignancies: a Prospective, Single-center Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 4, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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