MucormycosisNCT06900114
Disease Burden Transition of Mucormycosis in Hematologic Malignancies Population Across Covid 19 Era: a Single-center Comparative Analysis From China
An observational study of Mucormycosis and Hematologic Malignancies, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
The project intends to carry out a retrospective study on the epidemiology, predisposing factors, clinical manifestations, diagnosis, treatment, prognosis and economic burden of mucormycosis in a Chinese single-center allogeneic hematopoietic stem cell transplantation population. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mucormycosis, Hematologic Malignancies, COVID-19
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 8 Feb 2025to 30 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were diagnosed with mucormycosis(proven or probable) in accordance with the 2008 EORTC/MSG criteria and Revised EORTC/MSGERC 2020 Criteria. Mucormycosis is a rare opportunistic fungal infection typically characterized by rapid progression, the main susceptible population is patients with diabetes and severe underlying diseases of immunocompromised patients with poor glycemic control (e.g., hematologic malignancies, hematopoietic stem cell transplantation, solid organ transplantation, etc.)
Who may be able to join
- Patients with hematologic diseases who undergoes hematopoietic stem cell transplantation in the center from January 2015 to December 2023.
- Age≥18 years old.
- 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].
- The patients themselves or their authorized clients agree to participate in the clinical study and sign the informed consent.
Who cannot join
- 1. Patients with fungal infections other than mucormycosis were excluded.
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin
About this study
The project intends to carry out a retrospective study on the epidemiology, predisposing factors, clinical manifestations, diagnosis, treatment, prognosis and economic burden of mucormycosis in a Chinese single-center allogeneic hematopoietic stem cell transplantation population. The project was conducted at the Blood Diseases Hospital, Chinese Academy of Medical Sciences, which has rich experience in hematopoietic stem cell transplantation and has completed more than 3,000 cases of various types of HSCT, 400 allogeneic hematopoietic stem cell transplants per year, and routine bronchoscopy and application of guideline-recommended regimens for the treatment of mucormycosis. This study will objectively reflect the current management status of allogeneic hematopoietic stem cell transplantation combined with mucormycosis in Chinese transplant centers. Through systematic analysis of the changes in the management of mucormycosis in Chinese patients undergoing hematopoietic stem cell transplantation, to gain perspective into the impact of Covid19, diagnostic techniques, and new drugs on the incidence, diagnosis and treatment of mucormycosis . This will has a profound impact on optimizing the management strategies of mucormycosis in patients undergoing hematopoietic stem cell transplantation in the future.
Read the detailed description
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.
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:
- Incidence difference of invasive mucormycosis between two stages;
- Risk factors difference of invasive mucormycosis between two stages;
- Difference of Clinical types, imaging features and bronchoscopic features of invasive mucormycosis in hematologic malignancies between two stages;.
- Changing of etiology and histopathological results of invasive mucormycosis in hematologic malignancies between two stages;.
- History of antifungal drug exposure in hematologic malignancies patients with invasive mucormycosis;
- Treatment regimen and course changing of invasive mucormycosis
- Prognosis of invasive mucormycosis in hematologic malignancies patients;
- Economic burden transition of invasive mucormycosis in hematologic malignancies patients including average length of hospital stay, cost of antifungal therapy etc.
- Incidence and characteristics of invasive pulmonary mucormycosis in allogeneic hematopoietic stem cell transplantation patients during two stages.
- Conditions
- Mucormycosis, Hematologic Malignancies, COVID-19
- Keywords
- Mucormycosis, Hematologic Malignancies, COVID-19, China
- Medical subject headings
- Mucormycosis, Hematologic Neoplasms, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To summarize and compare the characteristics of Mucormycosis in Chinese hematologic malignancies population
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.
Measured: 2 YEARS
Secondary outcomes (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.
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.
Measured: 2 YEARS
Impact of treatment progress on disease prognosis and burden: the status of surgery changes
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.
Measured: 2 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start8 Feb 2025
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MucormycosisStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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-control
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06900114
- Sponsor's protocol ID
- QTJC2024056
- Status last verified
- Mar 2026
- First submitted
- 29 Nov 2024
- Last updated
- 5 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disease Burden Transition of Mucormycosis in Hematologic Malignancies Population Across Covid 19 Era: a Single-center Comparative Analysis From China
- ClinicalTrials.gov ID
- NCT06900114
- Acronym / sponsor ID
- QTJC2024056
- Conditions
- Mucormycosis, Hematologic Malignancies, COVID-19
- Keywords
- Mucormycosis, Hematologic Malignancies, COVID-19, China
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 8 Feb 2025 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 28 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The project intends to carry out a retrospective study on the epidemiology, predisposing factors, clinical manifestations, diagnosis, treatment, prognosis and economic burden of mucormycosis in a Chinese single-center allogeneic hematopoietic stem cell transplantation population. The project was conducted at the Blood Diseases Hospital, Chinese Academy of Medical Sciences, which has rich experience in hematopoietic stem cell transplantation and has completed more than 3,000 cases of various types of HSCT, 400 allogeneic hematopoietic stem cell transplants per year, and routine bronchoscopy and application of guideline-recommended regimens for the treatment of mucormycosis. This study will objectively reflect the current management status of allogeneic hematopoietic stem cell transplantation combined with mucormycosis in Chinese transplant centers. Through systematic analysis of the changes in the management of mucormycosis in Chinese patients undergoing hematopoietic stem cell transplantation, to gain perspective into the impact of Covid19, diagnostic techniques, and new drugs on the incidence, diagnosis and treatment of mucormycosis . This will has a profound impact on optimizing the management strategies of mucormycosis in patients undergoing hematopoietic stem cell transplantation in the future.
Detailed description
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.
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:
- Incidence difference of invasive mucormycosis between two stages;
- Risk factors difference of invasive mucormycosis between two stages;
- Difference of Clinical types, imaging features and bronchoscopic features of invasive mucormycosis in hematologic malignancies between two stages;.
- Changing of etiology and histopathological results of invasive mucormycosis in hematologic malignancies between two stages;.
- History of antifungal drug exposure in hematologic malignancies patients with invasive mucormycosis;
- Treatment regimen and course changing of invasive mucormycosis
- Prognosis of invasive mucormycosis in hematologic malignancies patients;
- Economic burden transition of invasive mucormycosis in hematologic malignancies patients including average length of hospital stay, cost of antifungal therapy etc.
- Incidence and characteristics of invasive pulmonary mucormycosis in allogeneic hematopoietic stem cell transplantation patients during two stages.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were diagnosed with mucormycosis(proven or probable) in accordance with the 2008 EORTC/MSG criteria and Revised EORTC/MSGERC 2020 Criteria. Mucormycosis is a rare opportunistic fungal infection typically characterized by rapid progression, the main susceptible population is patients with diabetes and severe underlying diseases of immunocompromised patients with poor glycemic control (e.g., hematologic malignancies, hematopoietic stem cell transplantation, solid organ transplantation, etc.)
Key inclusion criteria (4 listed)
- Patients with hematologic diseases who undergoes hematopoietic stem cell transplantation in the center from January 2015 to December 2023.
- Age≥18 years old.
- 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].
- The patients themselves or their authorized clients agree to participate in the clinical study and sign the informed consent.
Key exclusion criteria (1 listed)
- 1. Patients with fungal infections other than mucormycosis were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To summarize and compare the characteristics of Mucormycosis in Chinese hematologic malignancies population
Time frame: 2 YEARS
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 secondary outcomes
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.
Time frame: 2 YEARS
Impact of treatment progress on disease prognosis and burden: the status of surgery changes
Time frame: 2 YEARS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mucormycosis and Hematologic Malignancies, run by Institute of Hematology & Blood Diseases Hospital, China 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 1 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: finished, as of the sponsor's last update on 5 Mar 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To summarize and compare the characteristics of Mucormycosis in Chinese hematologic malignancies population (time frame: 2 YEARS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2026.