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This study is a prospective, multicenter, single-arm study, that aims to evaluate the efficacy and safety of amphotericin B cholesterol-sulfate complex (ABCD) for injection in the first-line treatment of patients with invasive fungal diseases, hoping to provide a reference for the clinical treatment of invasive fungal diseases. Patients with hematologic diseases who meet the criteria for inclusion and discharge with febrile neutropenia and suspected fungal infection were treated with ABCD antifungal therapy for 14 days while receiving treatment for underlying diseases, and the response rate of treatment was observed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amphotericin B cholesterol-sulfate complex (ABCD) | Experimental | Investigational drug: Amphotericin B cholesterol-sulfate complex (ABCD) at the same time as a treatment for underlying disease. Dosage: According to the patient's condition and the investigator's judgment, the initial dose of ABCD can be 0.5-1.0mg/kg/d, and the dose can be increased daily according to the situation, and the therapeutic dose can be increased to 3.0-4.0mg/kg/d on the third day. Course of treatment: ≥ 14 days (whether to continue to receive trial drug treatment after 14 days is decided by the investigator according to the patient's condition). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amphotericin B cholesterol-sulfate complex for injection | Drug | Patients were eligible for enrollment on antifungal therapy with injectable amphotericin B cholesterol-sulfate complex (ABCD) at the same time as a treatment for underlying disease. Dosage: According to the patient's condition and the investigator's judgment, the initial dose of ABCD can be 0.5-1.0mg/kg/d, and the dose can be increased daily according to the situation, and the therapeutic dose can be increased to 3.0-4.0mg/kg/d on the third day. Course of treatment: ≥ 14 days (whether to continue to receive trial drug treatment after 14 days is decided by the investigator according to the patient's condition). |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment is effective | A patient is considered successful if they meet the following five criteria: Starting antifungal treatment until no new fungal infections occur within 7 days after discontinuation of medication; Patient survival within 7 days after discontinuation of treatment; During the treatment period, the drug was not stopped due to side effects or lack of efficacy; After starting antifungal therapy, patients experience fever reduction during neutropenia (defined as body temperature<38 ℃ for more than 48 hours); Invasive fungal diseases diagnosed or clinically diagnosed (baseline fungal infection refers to fungal infection confirmed within 24-48 hours after initiation of antifungal treatment) achieve complete or partial efficacy at the end of treatment. Refer to the "Diagnostic Criteria and Treatment Principles for Invasive Fungal Disease in Patients with Hematological Diseases/Malignant Tumors (Sixth Revised Edition)" for the evaluation criteria for the treatment efficacy. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of the single index in the five criteria of treatment success | The incidence of a single indicator among the five criteria for treatment success mentioned in "Outcome 1" | 12 months |
| Completion rate of ABCD treatment for at least 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liu Qifa | Contact | 020-61641615 | liuqifa628@163.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25293517 | Result | Sun Y, Huang H, Chen J, Li J, Ma J, Li J, Liang Y, Wang J, Li Y, Yu K, Hu J, Jin J, Wang C, Wu D, Xiao Y, Huang X. Invasive fungal infection in patients receiving chemotherapy for hematological malignancy: a multicenter, prospective, observational study in China. Tumour Biol. 2015 Feb;36(2):757-67. doi: 10.1007/s13277-014-2649-7. Epub 2014 Oct 8. | |
| 25840339 |
| Label | URL |
|---|---|
| Related Info | View source |
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A summary report will be written and published after the clinical trial is completed, and the data from the summary report or article will be shared
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| ID | Term |
|---|---|
| D000072742 | Invasive Fungal Infections |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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Completion rate of ABCD treatment for at least 14 days
| 12 months |
| Sun Y, Meng F, Han M, Zhang X, Yu L, Huang H, Wu D, Ren H, Wang C, Shen Z, Ji Y, Huang X. Epidemiology, management, and outcome of invasive fungal disease in patients undergoing hematopoietic stem cell transplantation in China: a multicenter prospective observational study. Biol Blood Marrow Transplant. 2015 Jun;21(6):1117-26. doi: 10.1016/j.bbmt.2015.03.018. Epub 2015 Mar 31. |
| 32987477 | Result | Chinese Association Hematologists; Chinese Invasive Fungal Infection Working Group. [The Chinese guidelines for the diagnosis and treatment of invasive fungal disease in patients with hematological disorders and cancers (the 6th revision)]. Zhonghua Nei Ke Za Zhi. 2020 Oct 1;59(10):754-763. doi: 10.3760/cma.j.cn112138-20200627-00624. Chinese. |
| 9709879 | Result | White MH, Bowden RA, Sandler ES, Graham ML, Noskin GA, Wingard JR, Goldman M, van Burik JA, McCabe A, Lin JS, Gurwith M, Miller CB. Randomized, double-blind clinical trial of amphotericin B colloidal dispersion vs. amphotericin B in the empirical treatment of fever and neutropenia. Clin Infect Dis. 1998 Aug;27(2):296-302. doi: 10.1086/514672. |
| 10394018 | Result | Dupont B. Clinical efficacy of amphotericin B colloidal dispersion against infections caused by Candida spp. Chemotherapy. 1999 Jun;45 Suppl 1:27-33. doi: 10.1159/000048467. |
| 10394019 | Result | Gurwith M. Clinical efficacy of amphotericin B colloidal dispersion against infections caused by Aspergillus spp. Chemotherapy. 1999 Jun;45 Suppl 1:34-8. doi: 10.1159/000048468. |
| 11561801 | Result | Herbrecht R, Letscher-Bru V, Bowden RA, Kusne S, Anaissie EJ, Graybill JR, Noskin GA, Oppenheim, Andres E, Pietrelli LA. Treatment of 21 cases of invasive mucormycosis with amphotericin B colloidal dispersion. Eur J Clin Microbiol Infect Dis. 2001 Jul;20(7):460-6. doi: 10.1007/s100960100528. |
| 12145716 | Result | Bowden R, Chandrasekar P, White MH, Li X, Pietrelli L, Gurwith M, van Burik JA, Laverdiere M, Safrin S, Wingard JR. A double-blind, randomized, controlled trial of amphotericin B colloidal dispersion versus amphotericin B for treatment of invasive aspergillosis in immunocompromised patients. Clin Infect Dis. 2002 Aug 15;35(4):359-66. doi: 10.1086/341401. Epub 2002 Jul 25. |
| Result | Dong lu Zhao,Jun Ma. Guiding principle for the administration of amphotericin B colloidal dispersion for injection[J].Journal of Clinical Hematology, 2022, 35(5):6. DOI : 10.13201 / j.issn.1004-2806.2022.05.001. |