Fungal Infection Clinical Trial
Official title:
An Open,Multicenter Clinic Trial of the Effectiveness,Safety and Pharmacokinetics in the Empiric Therapy of Patients With Persistent Fever and Agranulocytosis Using Local Caspofungin
Verified date | December 2020 |
Source | Cttq |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
China | Affiliated Concord Hospital of Fujian Medical University | Fuzhou | Fujian |
China | The First Affiliated Hospital of Zhejiang University | Hangzhou | Zhejiang |
China | Qilu Hospital of Shandong University | Jinan | Shandong |
China | Jiangsu Province Hospital | Nanjing | Jiangsu |
China | Tongji Hospital of Shanghai | Shanghai | Shanghai |
China | The First Affiliated Hospital of Suzhou University | Suzhou | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Cttq |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy evaluation 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. | 7 days after drug withdrawal | |
Primary | Peak Plasma Concentration (Cmax) | The peak plasma concentration after injection of caspofungin | Day1,day3,day4 after the start of the dosing | |
Primary | Half-Life (t 1/2) | The time of duration from the starting of injection to half plasma concentration of caspofungin | Day1 after the start of the dosing | |
Primary | Area under the plasma concentration versus time curve (AUC) | The area under the plasma concentration of caspofungin versus time curve from Day1 to Day4 after the fist dosing | Day1,day3,day4 after the start of the study | |
Secondary | The duration of fever | The duration of the fever in patients | 7 days after drug withdrawal | |
Secondary | Survival rate | The number of surviving patients divided by the total number of patients | 7 days after drug withdrawal |
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