Clinical trial · Interventional
Efficacy and Safety of Micafungin for Injection in Prevention and Treatment of Fungal Infection in Hematological Tumors
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
NCT04738955CI-TRIAL-00049871unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematological Tumors Patients With High Risk Factors of Invasive Fungal Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Micafungin Sodium | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- High dose group
- description
- micafungin sodium ≥ 200, ≤ 300 mg/time, once a day, intravenous drip
- interventionNames
- Drug: Micafungin Sodium
Primary outcomes (1)
- measure
- clinical efficacy
- timeFrame
- 14 days
- description
- Breakthrough incidence of Invasive Fungal Infection (IFI), during prophylaxis use of micafungin
Secondary outcomes (2)
- measure
- Safety assessed by lab-test and adverse events
- timeFrame
- 30 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years old, male or female 2. Patients with hematological tumors 3. 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. 4. 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 5. 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. Exclusion Criteria: 1. The patient is being treated with an antifungal drug 2. People who are known or suspected to be allergic to echinocandins 3. The infection is suspected to be caused by parasites, viruses or Mycobacterium tuberculosis. 4. Existing drug sensitivity results suggest that patients resistant to micafungin 5. Severe chronic liver disease with Child-Pugh grade C 6. Fever caused by tumor 7. Micafungin in the Treatment of Fungal Infections Caused by Cryptococcus, Zygomycetes and Trichospora that Are Ineffective 8. Removal of the central venous catheter can effectively relieve fever, and it is difficult to determine whether micafungin is effective or not. 9. Patients who were not considered suitable for the research
References
Publications (0)
Data not yet available
No reference posted for this study.