Empiric Therapy of Patients With Persistent Fever and Agranulocytosis Using Caspofungin

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03857399
• Other study ID #: CTTQ-CORE-101
• Status: Completed
• Phase: Phase 2
• Start date: September 17, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: December 2020
• Source: Cttq
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Agranulocytosis
• Fungal Infection
• Mycoses

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Cttq

Country where clinical trial is conducted

China, 

Outcome

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