Hematological Tumors Patients With High Risk Factors of Invasive Fungal DiseasePhase 4NCT04738955
Efficacy and Safety of Micafungin for Injection in Prevention and Treatment of Fungal Infection in Hematological Tumors
A Phase 4 study testing Micafungin Sodium in people with Hematological Tumors Patients With High Risk Factors of Invasive Fungal Disease, run by Shandong Provincial Hospital at 1 site in China.
Trial summary
This is a multi-center, prospective, open, observational and optimal clinical research to evaluate the clinical effectiveness and safety of different doses of micafungin sodium for injection in patients with hematological tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematological Tumors Patients With High Risk Factors of Invasive Fungal Disease
- What is being tested?
- Micafungin Sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2021to 1 Oct 2023
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old, male or female
- Patients with hematological tumors
- Neutropenia: The absolute neutrophils count (ANC) in peripheral blood was 0.5×109/L or was expected to be ANC<0.5×109/L 48 hours later.
- Fever: single measurement of oral temperature ≥ 38.3℃ (axillary temperature ≥ 38.0℃) or oral temperature ≥ 38.0℃ (axillary temperature ≥ 37.7℃) lasts for more than 1h
- Patients with high risk factors of IFD (Invasive Fungal Disease), such as patients treated with allo-HSCT, patients with acute leukemia (including MDS) undergoing primary induction or rescue chemotherapy, patients with expected granulocytosis lasting more than 10 days, patients with severe granulocytosis or patients with severe aplastic anemia receiving antithymic globulin (ATG) therapy or HSCT therapy, etc.
Who cannot join
- The patient is being treated with an antifungal drug
- People who are known or suspected to be allergic to echinocandins
- The infection is suspected to be caused by parasites, viruses or Mycobacterium tuberculosis.
- Existing drug sensitivity results suggest that patients resistant to micafungin
- Severe chronic liver disease with Child-Pugh grade C
- Fever caused by tumor
Show all 9Show fewer
- Micafungin in the Treatment of Fungal Infections Caused by Cryptococcus, Zygomycetes and Trichospora that Are Ineffective
- Removal of the central venous catheter can effectively relieve fever, and it is difficult to determine whether micafungin is effective or not.
- Patients who were not considered suitable for the research
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Hematology, Provincial Hospital Affiliated to Shandong University
Jinan, Shandong, 250021
changqing zhen, MD, 86-531-68778331, zcq1521@163.com
About this study
Official title: Prospective, Observational and Cohort Clinical Research on Clinical Efficacy and Safety of Different Doses of Micafungin Sodium for Injection in Prevention and Treatment of Fungal Infection in Patients With Hematological Tumors
This is a multi-center, prospective, open, observational and optimal clinical research to evaluate the clinical effectiveness and safety of different doses of micafungin sodium for injection in patients with hematological tumors.
Read the detailed description
This is a multi-center, prospective, open, observational and optimal clinical research to evaluate the clinical effectiveness and safety of different doses of micafungin sodium for injection in patients with hematological tumors. Researchers screened suitable subjects according to the admission criteria, and after signing the informed consent form, micafungin sodium for injection was used for preventive or empirical treatment. During the treatment period, subjects who need to change the treatment plan due to uncontrollable infection or other reasons will withdraw from this research and the researchers will decide the follow-up treatment plan.All subjects were monitored for efficacy and safety according to the visit plan during the research.
- Being tested
- Micafungin Sodium
- Keywords
- hematological tumors, Invasive Fungal Disease
- Medical subject headings
- Hematologic Neoplasms, Invasive Fungal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micafungin SodiumDrug
micafungin sodium ≥ 100, <200mg/time, once a day, intravenous drip. Low dose group
| Study group | Role | What they receive |
|---|---|---|
| High dose group | Experimental | micafungin sodium ≥ 200, ≤ 300 mg/time, once a day, intravenous drip Receives: Drug: Micafungin Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical efficacy
Breakthrough incidence of Invasive Fungal Infection (IFI), during prophylaxis use of micafungin
Measured: 14 days
Secondary outcomes (2)
Safety assessed by lab-test and adverse events
Incidence of adverse reactions in different dose groups of micafungin
Measured: 30 days
Survival rate
IFD-related mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start1 Feb 2021
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological Tumors Patients With High Risk Factors of Invasive Fungal DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The patients will be randomized either low dose group or high dose group
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Wang Xin, Shandong Provincial Hospital
- Investigators
- xin wang, MD, PHD, Study chair, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04738955
- Sponsor's protocol ID
- ShandongPH12
- Status last verified
- Feb 2021
- First submitted
- 16 Jan 2021
- Last updated
- 4 Feb 2021
- 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 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Observational and Cohort Clinical Research on Clinical Efficacy and Safety of Different Doses of Micafungin Sodium for Injection in Prevention and Treatment of Fungal Infection in Patients With Hematological Tumors
- ClinicalTrials.gov ID
- NCT04738955
- Acronym / sponsor ID
- ShandongPH12
- Keywords
- hematological tumors, Invasive Fungal Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 4 Feb 2021 (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.
This is a multi-center, prospective, open, observational and optimal clinical research to evaluate the clinical effectiveness and safety of different doses of micafungin sodium for injection in patients with hematological tumors.
Detailed description
This is a multi-center, prospective, open, observational and optimal clinical research to evaluate the clinical effectiveness and safety of different doses of micafungin sodium for injection in patients with hematological tumors. Researchers screened suitable subjects according to the admission criteria, and after signing the informed consent form, micafungin sodium for injection was used for preventive or empirical treatment. During the treatment period, subjects who need to change the treatment plan due to uncontrollable infection or other reasons will withdraw from this research and the researchers will decide the follow-up treatment plan.All subjects were monitored for efficacy and safety according to the visit plan during the research.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The patients will be randomized either low dose group or high dose group
| Arm | Type | Receives |
|---|---|---|
| High dose group | Experimental | Drug: Micafungin Sodiummicafungin sodium ≥ 200, ≤ 300 mg/time, once a day, intravenous drip |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years old, male or female
- Patients with hematological tumors
- Neutropenia: The absolute neutrophils count (ANC) in peripheral blood was 0.5×109/L or was expected to be ANC<0.5×109/L 48 hours later.
- Fever: single measurement of oral temperature ≥ 38.3℃ (axillary temperature ≥ 38.0℃) or oral temperature ≥ 38.0℃ (axillary temperature ≥ 37.7℃) lasts for more than 1h
- Patients with high risk factors of IFD (Invasive Fungal Disease), such as patients treated with allo-HSCT, patients with acute leukemia (including MDS) undergoing primary induction or rescue chemotherapy, patients with expected granulocytosis lasting more than 10 days, patients with severe granulocytosis or patients with severe aplastic anemia receiving antithymic globulin (ATG) therapy or HSCT therapy, etc.
Key exclusion criteria (9 listed)
- The patient is being treated with an antifungal drug
- People who are known or suspected to be allergic to echinocandins
- The infection is suspected to be caused by parasites, viruses or Mycobacterium tuberculosis.
- Existing drug sensitivity results suggest that patients resistant to micafungin
- Severe chronic liver disease with Child-Pugh grade C
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micafungin Sodiummicafungin sodium ≥ 100, <200mg/time, once a day, intravenous drip. Low dose group | Drug | High dose group |
Primary outcome
clinical efficacy
Time frame: 14 days
Breakthrough incidence of Invasive Fungal Infection (IFI), during prophylaxis use of micafungin
2 secondary outcomes
Safety assessed by lab-test and adverse events
Time frame: 30 days
Survival rate
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
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.
xin wang, MD, PHD study chair
Shandong Provincial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Micafungin Sodium in people with Hematological Tumors Patients With High Risk Factors of Invasive Fungal Disease, run by Shandong Provincial 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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 4 Feb 2021. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xin wang, MD, PHD (86-531-68778331, xinw007@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical efficacy (time frame: 14 days). 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 4 Feb 2021; AzTrials last refreshed its copy on 8 Nov 2026.