A Clinical Study on the Efficacy and Safety of ABCD in the Treatment of Patients With Invasive Fungal Disease
NCT ID: NCT06376201
Last Updated: 2024-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
125 participants
INTERVENTIONAL
2024-04-30
2025-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Amphotericin B cholesterol-sulfate complex (ABCD)
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).
Amphotericin B cholesterol-sulfate complex for injection
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).
Interventions
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Amphotericin B cholesterol-sulfate complex for injection
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).
Eligibility Criteria
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Inclusion Criteria
2. Patients with hematologic malignancies such as leukemia and lymphoma who have undergone chemotherapy or hematopoietic stem cell transplantation;
3. Peripheral blood absolute neutrophil count (ANC) \< 0.5×109/L, or expected ANC \< 0.5×109/L after 48 h;
4. Within 48 hours before the screening, at least 2 oral temperature measurements (with an interval of more than 30 minutes) ≥ 38.3°C (axillary temperature≥38.0°C), or ≥ 38°C (axillary temperature≥37.7°C) for more than 1h;
5. Received broad-spectrum antimicrobial therapy for at least 96 hours before screening but still had recurrent or persistent fever and suspected fungal infection;
6. The patient or his/her legal representative signs the informed consent form.
Exclusion Criteria
2. Patients with clinical suspicion of invasive fungal disease who have received antifungal therapy;
3. Patients with clinically diagnosed or confirmed invasive fungal disease (IFD) during the screening period;
4. Patients with abnormal liver function, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 5 times the upper limit of normal (ULN), or ALT or AST \> 3 times ULN and total bilirubin \> 1.5 times ULN;
5. Patients with reduced renal function, who need or are currently undergoing hemodialysis or peritoneal dialysis;
6. Clinically significant hypokalemia (defined as serum potassium \< 3.2 mmol/L, or blood potassium lower than the lower limit of normal while receiving digitalis therapy), and hypokalemia cannot be corrected before starting trial treatment;
7. Expected survival time\< 3 months;
8. Pregnant women, lactating women, or women of childbearing age who have not taken contraceptive measures and are planning to become pregnant;
9. Other investigators believe that it is not appropriate to participate in clinical trials.
18 Years
ALL
No
Sponsors
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Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Other Identifiers
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NFEC-2024-018
Identifier Type: -
Identifier Source: org_study_id
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