invasive candidiasis and invasive aspergillosis
Conditions
Interventions
Experimental group:Inject amphotericin B cholesterol sulfate complex
Sponsors
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old, regardless of sex; 2. Subjects diagnosed as invasive candidiasis (confirmed diagnosis) or invasive aspergillosis (confirmed diagnosis or clinical diagnosis) according to the Revised Definition of Invasive Mycosis and conforming to EORTC-MSG diagnostic criteria: IC confirmed that the subjects were positive reports of candida culture in blood or other sterile parts samples obtained within 48 hours before entering the group; Or the histopathological/cytopathological examination report of needle aspiration or biopsy samples from normal sterile parts except mucosa obtained within 2 weeks shows candida; IA confirmed that the subjects were pathological tissues (sterile samples) obtained within 4 weeks before entering the group, which clearly contained fungal components (through cytological examination, microscopic examination or culture, etc.). The clinical diagnosis of IA includes at least one host factor, one clinical standard and one microbiological standard (serum, sputum, bronchoalveolar lavage fluid, bronchial brush specimen, or nasal sinus extract, etc. indicate that Aspergillus GM test is positive); 3. All subjects agreed to contraception from the signing of informed consent to the end of the last medication for 6 weeks; 4. Female subjects must meet one of the following conditions: they have been surgically sterilized; Menopause, menopause for at least 1 year; Or have fertility, but the results of serum examination of human chorionic gonadotropin (HCG) were negative. And agreed to take an approved and very effective contraceptive measure, and the contraceptive method remained unchanged during the whole study period; 5. Male subjects must have been surgically sterilized or their female partners meet any of the above-mentioned Article 4, and their contraceptive methods will remain unchanged during the study; 6. Subjects and/or guardians are fully aware of the contents of the experiment and are willing to participate in the experiment and sign an informed consent form in writing.
Exclusion criteria
Exclusion criteria: 1. Those who are allergic to amphotericin B drugs or azole antifungal drugs; 2. IC subjects received >= 3 days of systemic antifungal treatment within 1 week before enrollment; 3. IA subjects received more than 96 hours of systemic antifungal therapy within 1 week before enrollment, or used prophylactic medication for more than 13 days, or used amphotericin B common preparations with a cumulative dose of more than 10 mg/kg within 10 days before enrollment , or use a cumulative dose of more than 15 mg/kg amphotericin lipid preparation (fengkesone); 4. Evidence of subject infection is limited to urine (except those diagnosed with pyelonephritis), sputum and bronchoalveolar lavage fluid, catheter tip, drainage fluid or other mucosal or superficial skin surfaces (such as vagina or other external genitalia, colon , oropharynx, esophagus, skin folds, nail beds, etc.) positive Candida culture; 5. Subjects suspected of Candida endocarditis, osteomyelitis, arthritis, endophthalmitis, hepatosplenic abscess, suppurative thrombophlebitis or central nervous system infection; 6. Candida specimens collected 24 hours after the catheter or drainage tube was placed in the sterile site were not positive for the first time; 7. Subjects with invasive candidiasis related to intravenous catheterization, and the catheter cannot be removed or replaced during the study; 8. Subjects with chronic pulmonary aspergillosis (duration >= 3 months), aspergilloma or allergic bronchopulmonary aspergillosis; 9. Known subjects suffer from mixed invasive Candida or Aspergillus infections, such as invasive Aspergillus terreus and Aspergillus nidulans; 10. Subjects who installed artificial devices (except intravenous catheters) and were suspected to be the source of infection, and could not remove the device within 24 hours after enrollment; 11. Abnormal liver function [aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >= 5 times the upper limit of normal value without accompanied by elevated total bilirubin, or elevated ALT or AST upper limit of normal value 3 1.5-fold increase in total bilirubin] subjects; 12. Subjects with impaired renal function who need or are currently undergoing hemodialysis or peritoneal dialysis; 13. Clinically significant hypokalemia, which cannot be corrected before starting the trial treatment; 14. Subjects who plan to use prohibited drugs during the study; 15. Those with an expected survival period of less than 2 months; 16. Unstable medical conditions other than hematopoietic system diseases, such as cardiac or nervous system disorders or impairments, which are expected to be unstable or progress during the course of the study; 17. In the absence of a cardiac pacemaker, the 12-lead ECG shows II-degree type 2 or III-degree atrioventricular block, long QT syndrome, or QTc > 470 ms (female)/450ms (male); 18. Subjects with NYHA grade III/IV cardiac function; 19. HIV antibody screening positive; 20. Pregnant and lactating women; 21. Those who have a history of drug abuse (narcotic drugs or psychotropic drugs for non-medical purposes) and drug dependence (sedative hypnotics, analgesics, narcotics, stimulants, and antipsychotic drugs, etc.); 22. Subjects who have participated in other drug or medical device clinical trials within three months before screening; 23. Subjects who have participated in this study (except for those who have used this product in the past and have been eluted for 5 half-lives or 14 days before screening); 24. S
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events;Characteristics of Adverse Events; | — |
Secondary
| Measure | Time frame |
|---|---|
| population pharmacokinetic;response rates;Recurrence rate;all-cause mortality; | — |
Countries
China
Contacts
Public ContactFeng Sizhou
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed