Empiric Therapy of Patients With Persistent Fever and Agranulocytosis Using Caspofungin
מילות מפתח
תַקצִיר
תיאור
Caspofungin, a member of the new echinocandin class of compounds，had been proved as effective as and generally better tolerated than liposomal amphotericin B when given as empirical antifungal therapy in patients with persistent fever and neutropenia，and It was approved by FDA in 2001.The generics caspofungin of Chia Tai TianQing Pharmaceutical Group Co. , Ltd. (CTTQ) will be approved by CFDA.The purpose of this study is evaluating the efficacy and safety of this generics caspofungin in the empirical antifungal therapy in patients with persistent fever and neutropenia.
This is a prospective,multicenter,randomized,controlled,open label study,the designed cases are 60 subjects.This study is divided into two stages,one is pharmacokinetics study stage ,the purpose of this stage is comparing the blood concentration of generics caspofungin and original medicine(Cancidas®) ,24 of 60 subjects will participate in this stage,the randomization in a 1:1 ratio will be performed at each group.The other 36 subjects will participate in another stage that is a single study,all subjects will use generics caspofungin.
תאריכים
| אומת לאחרונה: | 01/31/2019 |
| הוגש לראשונה: | 11/15/2018 |
| ההרשמה המשוערת הוגשה: | 02/25/2019 |
| פורסם לראשונה: | 02/27/2019 |
| העדכון האחרון הוגש: | 02/25/2019 |
| עדכון אחרון פורסם: | 02/27/2019 |
| תאריך תחילת לימוד בפועל: | 09/16/2018 |
| תאריך סיום משוער משוער: | 08/31/2019 |
| תאריך סיום משוער ללימודים: | 11/30/2019 |
מצב או מחלה
התערבות / טיפול
Drug: Caspofungin
שלב
קבוצות זרועות
| זְרוֹעַ | התערבות / טיפול |
|---|---|
| Experimental: Arm-1 Patients will be assigned to receive intravenous local caspofungin (70 mg on day 1 and 50 mg once daily),If the study therapy was well tolerated but fever persisted for four or more days and the patient's clinical condition deteriorated, the dosage could be increased to 70 mg once daily.For patients who have no evidence of baseline or breakthrough fungal infection, study therapy was administered until the absolute neutrophil count was at least 500 per cubic millimeter and for up to 72 hours thereafter. The onsite investigator determined the duration of therapy for patients with baseline or breakthrough fungal infections; however,it was recommended that treatment be given for at least 14 days and for at least 7 days after neutropenia and symptoms resolved. | |
| Active Comparator: Arm-2 Patients will be assigned to receive intravenous original caspofungin (70 mg on day 1 and 50 mg once daily),the therapeutical duration is 4 Days. |
קריטריונים לזכאות
| גילאים הזכאים ללימודים | 18 Years ל 18 Years |
| מינים הזכאים ללימודים | All |
| מקבל מתנדבים בריאים | כן |
| קריטריונים | Inclusion Criteria: - Age 18-70 years old - The neutrophil counts of the patients with leukemia, lymphoma or other tumors undergoing chemotherapy or receiving hematopoietic stem cell transplantation are below 500 million/L for 96 hours at least,as well as the body temperatures are over 38.0 °C; - It is ineffective using intravenous broad-spectrum antibacterial therapy lasting at least 96h; - Estimated survival period > 3 months; - Subjects voluntarily participate in the study and sign informed consent. Exclusion Criteria: - The subjects did not receive adequate antibacterial therapy; - The subjects were received other antifungal medications within 14 days (except for fluconazole prophylaxis); - It was confirmed or clinically diagnosed as invasive fungal infection; - Subjects with liver dysfunction (ALT, AST exceeds the upper limit of normal value by 2 times); - Subjects with renal insufficiency (Cr, BUN exceeds the upper limit of the normal value of 1.5 times); - Subjects are allergic to the investigational product; - Pregnant or lactating women; - Simultaneous treatment with cyclosporine, tacrolimus, rifampicin, efavirenz, nevirapine, dexamethasone, phenytoin or carbamazepine; - Other circumstances that investigators believe unsuitable for enrollment; （criteria 8 does not apply to Phase 2） |
תוֹצָאָה
מדדי תוצאות ראשוניים
1. Efficacy evaluation 7 days after drug withdrawal [7 days after drug withdrawal]
2. Peak Plasma Concentration (Cmax) [Day1,day3,day4 after the start of the dosing]
3. Half-Life (t 1/2) [Day1 after the start of the dosing]
4. Area under the plasma concentration versus time curve (AUC) [Day1,day3,day4 after the start of the study]
אמצעי תוצאה משניים
1. The duration of fever [7 days after drug withdrawal]
2. Survival rate [7 days after drug withdrawal]
