Disease Burden Transition of Mucormycosis in Hematologic Malignancies Population Across Covid 19 Era: a Single-center Comparative Analysis From China
NCT ID: NCT06900114
Last Updated: 2025-03-28
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
60 participants
OBSERVATIONAL
2023-10-07
2025-10-31
Brief Summary
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Detailed Description
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Objectives:
1.Conduct a comparative analysis in 2015-2020 stage (Pre-Covid Era) and 2020-2024 stage (Covid Era). To summarize and compare the characteristics of Mucormycosis in Chinese hematologic malignancies population from the aspects of incidence, mucorus species, types of mucormycosis, diagnostic techniques, treatment methods (surgical +drugs), pharmaceutical economics and prognosis between two stages. Objectively reflect the current management status of Mucormycosis in this population.
2 Analyze the possible causes of the epidemiology changing of mucormycosis: COVID19 influence, the advancement of diagnostic technology(NGS, respiratory endoscope intervention technique etc.) and other factors.
3 Impact of treatment progress on disease prognosis and burden: the status of surgery changes; To investigate the efficacy, safety and therapeutic status of posaconazole and other antifungal drugs in the treatment of Mucormycosis, and analyze the impact of the new antifungal drugs on the prognosis.
Data collection:
According to the information provided in the medical records and test results, enter the relevant data: including baseline characteristics, complications, clinical manifestations, laboratory tests, bronchoscopy results, imaging findings, fungal prophylaxis medication, therapeutic medication, surgical conditions and prognosis.
Results:
1. Incidence difference of invasive mucormycosis between two stages;
2. Risk factors difference of invasive mucormycosis between two stages;
3. Difference of Clinical types, imaging features and bronchoscopic features of invasive mucormycosis in hematologic malignancies between two stages;.
4. Changing of etiology and histopathological results of invasive mucormycosis in hematologic malignancies between two stages;.
5. History of antifungal drug exposure in hematologic malignancies patients with invasive mucormycosis;
6. Treatment regimen and course changing of invasive mucormycosis
7. Prognosis of invasive mucormycosis in hematologic malignancies patients;
8. Economic burden transition of invasive mucormycosis in hematologic malignancies patients including average length of hospital stay, cost of antifungal therapy etc.
9. Incidence and characteristics of invasive pulmonary mucormycosis in allogeneic hematopoietic stem cell transplantation patients during two stages.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Pre-Covid 19 group
Divide the patients into pre-covid 19 group(2015.01-2019.12) and covid 19 group(2020.1-2023.12) according to the time period.
No interventions assigned to this group
Covid 19 group
Divide the patients into pre-covid 19 group(2015.01-2019.12) and covid 19 group(2020.1-2023.12) according to the time period.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Ageā„18 years old.
3. Patients who were diagnosed with mucormycosis(proven or probable) in accordance with the 2008 EORTC/MSG criteria and Revised EORTC/MSGERC 2020 Criteria.\[8\]\[9\].
4. The patients themselves or their authorized clients agree to participate in the clinical study and sign the informed consent.
Exclusion Criteria
18 Years
75 Years
ALL
No
Sponsors
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Institute of Hematology & Blood Diseases Hospital, China
OTHER
Responsible Party
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Locations
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Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, , China
Countries
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Other Identifiers
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QTJC2024056
Identifier Type: -
Identifier Source: org_study_id
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