Clinical trial NCT03857399: Empiric Therapy of Patients With Persistent Fever and Agranulocytosis Using Caspofungin
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fungal Infection
Lead sponsor: Cttq
Sponsor class: INDUSTRY
First posted: 2019-02-28
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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）

Primary outcomes:
measure: Efficacy evaluation 7 days after drug withdrawal
timeFrame: 7 days after drug withdrawal
measure: Peak Plasma Concentration (Cmax)
timeFrame: Day1,day3,day4 after the start of the dosing
measure: Half-Life (t 1/2)
timeFrame: Day1 after the start of the dosing
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: Day1,day3,day4 after the start of the study
Secondary outcomes:
measure: The duration of fever
timeFrame: 7 days after drug withdrawal
measure: Survival rate
timeFrame: 7 days after drug withdrawal
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Affiliated Concord Hospital of Fujian Medical University
state: Fujian
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Suzhou University
state: Jiangsu
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Shanghai
country: China
facility: Tongji Hospital of Shanghai
state: Shanghai
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: Affiliated Concord Hospital of Fujian Medical University
name: Jianda Hu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: