Empiric Therapy of Patients With Persistent Fever and Agranulocytosis Using Caspofungin

NCT ID: NCT03857399

Last Updated: 2021-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-17
• Study Completion Date: 2019-12-31

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.

Conditions

Fungal Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm-1

Patients will be assigned to receive intravenous local caspofungin (70 mg on day 1 and 50 mg once daily),If the study therapy was well tolerated but fever persisted for four or more days and the patient's clinical condition deteriorated, the dosage could be increased to 70 mg once daily.For patients who have no evidence of baseline or breakthrough fungal infection, study therapy was administered until the absolute neutrophil count was at least 500 per cubic millimeter and for up to 72 hours thereafter. The onsite investigator determined the duration of therapy for patients with baseline or breakthrough fungal infections; however,it was recommended that treatment be given for at least 14 days and for at least 7 days after neutropenia and symptoms resolved.

Group Type: EXPERIMENTAL

Caspofungin

Intervention Type: DRUG

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

Arm-2

Patients will be assigned to receive intravenous original caspofungin (70 mg on day 1 and 50 mg once daily),the therapeutical duration is 4 Days.

Group Type: ACTIVE_COMPARATOR

Caspofungin

Intervention Type: DRUG

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

Interventions

Caspofungin

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

Intervention Type: DRUG

Other Intervention Names

original 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）

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cttq

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianda Hu, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Affiliated Concord Hospital of Fujian Medical University

Locations

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

Tongji Hospital of Shanghai

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

CTTQ-CORE-101

Identifier Type: -

Identifier Source: org_study_id