Invasive pulmonary mycosis in patients with hematological malignancies
Conditions
Interventions
azole:(1)Voriconazole: 6 mg/kg by intravenous injection or 300 mg orally twice, on the first day, followed by 4 mg/kg by intravenous injection or 200 mg orally twice, for the 2nd to 84th consecutive d
nebulized inhalation of amphotericin B deoxycholate (AmB-D) combined with azole:On the basis of standard azole antifungal therapy (voriconazole, esaconazole, posaconazole), nebulized inhalation of AmB
Sponsors
Shang Jin Hospital of West China Hospital,Sichuan University/Chengdu Shang Jin Nan Fu Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Age: 18-70 years old. (2) Gender is not limited; (3) Patients with hematological tumors; (4) Confirmed, clinically diagnosed or proposed to be diagnosed as invasive pulmonary mycosis; (5) Sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) A known history of allergy, hypersensitivity or any severe reaction to any component of azole antifungal drugs or investigational drugs; (2) There is a history of allergic asthma, chronic aspergillosis, aspergilloma or allergic bronchopulmonary aspergillosis in the past; (3) Severe renal insufficiency (creatinine clearance rate = 3 × upper limit of normal [ULN], alanine aminotransferase or aspartate aminotransferase >= 5 × ULN, liver cirrhosis or chronic liver failure); (5) Patients with respiratory failure who require ventilator-assisted ventilation; (6) Patients in the severe infection stage (sepsis, septic shock, multi-drug resistance, etc.); (7) Have received antifungal treatment with amphotericin B in any form within the recent one month; (8) The previous use of azole for preventive antifungal effects was not satisfactory; (9) Research participants with active pulmonary infections caused by Mycobacterium tuberculosis or nontuberculous mycobacterium; (10) Research participants with other forms of pulmonary aspergillosis (allergic bronchopulmonary aspergillosis, chronic aspergillosis and aspergilloma); (11) Patients with contraindications to azole and amphotericin B, including cardiovascular diseases (myocardial infarction, etc.); (12) High-risk patients with prolonged QT/QTc (Baseline prolonged QTcF >= 500 ms;) Torsional ventricular tachycardia at the tip At the same time, use drugs that prolong the QT/QTc interval; (13) Concurrent use of sirolimus, efavelon, ritonavir, asimidazole, cisapride, rifampicin, rifampicin, ergotic alkaloids, long-acting barbiturates, carbamazepine, quinidine, neosamine, terfinadine, ketoconazole, valproic acid, etc. within 5 days before the first administration; (14) Research participants who need to receive concurrent treatment with other drugs with contraindications such as azole or amphotericin B in this study; (15) Patients with human immunodeficiency virus syndrome; (16) Pregnant; (17) Research participants who refused to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Computed Tomography (CT) of the Chest; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale was used to evaluate cough, expectoration, hemoptysis, etc;Medical Research Council was used to evaluate dyspnea;Etiological evaluation of fungal infections; | — |
Countries
China
Contacts
Public ContactYongqian Jia
Chengdu Shang Jin Nan Fu Hospital/West China Hospital,Sichuan University
Outcome results
None listed