Status:
COMPLETED
Empiric Therapy of Patients With Persistent Fever and Agranulocytosis Using Caspofungin
Lead Sponsor:
Cttq
Conditions:
Fungal Infection
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 pharm...
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...
Eligibility Criteria
Inclusion
- 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
- 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）
Key Trial Info
Start Date :
September 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03857399
Start Date
September 17 2018
End Date
December 31 2019
Last Update
July 7 2021
Active Locations (6)
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1
Affiliated Concord Hospital of Fujian Medical University
Fuzhou, Fujian, China
2
Jiangsu Province Hospital
Nanjing, Jiangsu, China
3
The First Affiliated Hospital of Suzhou University
Suzhou, Jiangsu, China
4
Qilu Hospital of Shandong University
Jinan, Shandong, China