Fungal Infection
Conditions
Brief summary
The purpose of this study is evaluating the efficacy and safety of generics caspofungin in the treatment of the patients with neutropenic and fever.Another purpose of this study is comparing the pharmacokinetic characteristics of generics caspofungin and original medicine(Cancidas®) for providing a basis for clinical rational administration.
Detailed description
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.
Interventions
DRUGCaspofungin
Considering the possibility of fungal infection, we take empiric therapy for the patients with persistent fever and agranulocytosis using caspofungin for injection.
Sponsors
Cttq
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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）
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy evaluation 7 days after drug withdrawal | 7 days after drug withdrawal | Curative effect evaluation consists of five parts:The fever subsided during agranulocytosis; Breakthrough invasive fungal infections do not occur during or within 7 days after treatment; If any baseline invasive fungal infection is present, the therapy is effective; The patient was still alive when 7 days after drug withdrawal; The study was not terminated for drug-related toxicity or lacking of efficacy. |
| Peak Plasma Concentration (Cmax) | Day1,day3,day4 after the start of the dosing | The peak plasma concentration after injection of caspofungin |
| Half-Life (t 1/2) | Day1 after the start of the dosing | The time of duration from the starting of injection to half plasma concentration of caspofungin |
| Area under the plasma concentration versus time curve (AUC) | Day1,day3,day4 after the start of the study | The area under the plasma concentration of caspofungin versus time curve from Day1 to Day4 after the fist dosing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The duration of fever | 7 days after drug withdrawal | The duration of the fever in patients |
| Survival rate | 7 days after drug withdrawal | The number of surviving patients divided by the total number of patients |
Countries
China
Outcome results
None listed