NCT03857399

Empiric Therapy of Patients With Persistent Fever and Agranulocytosis Using Caspofungin

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Cttq · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fungal Infection

Interventions

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

Timeline

• Start date: 2018-09-17
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2019-02-28
• Last updated: 2021-07-07

Locations

6 sites across 1 country: China