Empiric Therapy of Patients With Persistent Fever and Agranulocytosis Using Caspofungin

Cttq32 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Fungal Infection

Interventions

CaspofunginDRUG

Considering the possibility of fungal infection, we take empiric therapy for the patients with persistent fever and agranulocytosis using caspofungin for injection.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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）

Locations (6)

Affiliated Concord Hospital of Fujian Medical University

Fuzhou, Fujian, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

The First Affiliated Hospital of Suzhou University

Suzhou, Jiangsu, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Outcomes

Primary Outcomes

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.

Time frame: 7 days after drug withdrawal

Peak Plasma Concentration (Cmax)

The peak plasma concentration after injection of caspofungin

Time frame: Day1,day3,day4 after the start of the dosing

Half-Life (t 1/2)

The time of duration from the starting of injection to half plasma concentration of caspofungin

Time frame: Day1 after the start of the dosing

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

Time frame: Day1,day3,day4 after the start of the study

Secondary Outcomes

The duration of fever

The duration of the fever in patients

Time frame: 7 days after drug withdrawal

Survival rate

The number of surviving patients divided by the total number of patients

Time frame: 7 days after drug withdrawal

Data from ClinicalTrials.gov

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