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Invasive AspergillosisNCT06583512

Treatment Duration of IPA

An observational study of Invasive Aspergillosis and Antifungal Therapy, run by Peking University People's Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Invasive Aspergillosis, Antifungal Therapy
How many people
15 participants
Where
1 siteChina
Study dates
1 Dec 2024to 31 Aug 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

Other trials in China

About this study

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

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.

Read the 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 weeks after discontinuation of posaconazole-initiated antifungal therapy

Secondary outcomes (7)

  1. 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

    Measured: 12 weeks after discontinuation of posaconazole-initiated antifungal therapy

  2. 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

    Measured: 12 weeks after discontinuation of posaconazole-initiated antifungal therapy

  3. Clinical success rate of posaconazole-initiated antifungal therapy

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

    Measured: 12 weeks after discontinuation of posaconazole-initiated antifungal therapy

  4. 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

    Measured: 12 weeks after discontinuation of posaconazole-initiated antifungal therapy

  5. 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.

    Measured: 12 weeks after discontinuation of posaconazole-initiated antifungal therapy

  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)

    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.

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

  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)

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2024
  2. Study start1 Dec 2024
  3. Primary completion31 Aug 2025 (estimated)
  4. Study completion31 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06583512
Sponsor's protocol ID
2024PHB035-001
Status last verified
Nov 2024
First submitted
6 Aug 2024
Last updated
27 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Invasive Aspergillosis and Antifungal Therapy, run by Peking University People's Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06583512.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.

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