Treatment Duration of IPA

NCT06583512 | Active Not Recruiting

• 1 other identifier: 2024PHB035-001
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Invasive Aspergillosis; Antifungal Therapy

Outcome Measures

Primary Outcomes (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

  12 weeks after discontinuation of posaconazole-initiated antifungal therapy

Secondary Outcomes (7)

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

  12 weeks after discontinuation of posaconazole-initiated antifungal therapy

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

  12 weeks after discontinuation of posaconazole-initiated antifungal therapy

• Clinical success rate of posaconazole-initiated antifungal therapy

  12 weeks after discontinuation of posaconazole-initiated antifungal therapy

• The proportion of patients who restarted treatment after discontinuation

  12 weeks after discontinuation of posaconazole-initiated antifungal therapy

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

  12 weeks after discontinuation of posaconazole-initiated antifungal therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Study Officials

• Yuqian Sun

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: September 4, 2024
• Study Start: December 1, 2024
• Primary Completion: August 31, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: December 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)