Empiric Therapy of Patients With Persistent Fever and Agranulocytosis Using Caspofungin

• Status: Completed
• Trial end date: 2019-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cttq
• Treatments: Caspofungin; Echinocandins

Criteria

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）