Back to resultsEmpiric Therapy of Patients With Persistent Fever and Agranulocytosis Using Caspofungin
Primary Purpose
Fungal Infection
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Caspofungin
Sponsored by
About this trial
This is an interventional treatment trial for Fungal Infection
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）
Sites / Locations
- Affiliated Concord Hospital of Fujian Medical University
- Jiangsu Province Hospital
- The First Affiliated Hospital of Suzhou University
- Qilu Hospital of Shandong University
- Tongji Hospital of Shanghai
- The First Affiliated Hospital of Zhejiang University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm-1
Arm-2
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Peak Plasma Concentration (Cmax)
The peak plasma concentration after injection of caspofungin
Half-Life (t 1/2)
The time of duration from the starting of injection to half plasma concentration of caspofungin
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
Secondary Outcome Measures
The duration of fever
The duration of the fever in patients
Survival rate
The number of surviving patients divided by the total number of patients
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03857399
Brief Title
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
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
September 17, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cttq
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fungal Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm-1
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm-2
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Caspofungin
Other Intervention Name(s)
original caspofungin
Intervention Description
Considering the possibility of fungal infection, we take empiric therapy for the patients with persistent fever and agranulocytosis using caspofungin for injection.
Primary Outcome Measure Information:
Title
Efficacy evaluation 7 days after drug withdrawal
Description
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
Title
Peak Plasma Concentration (Cmax)
Description
The peak plasma concentration after injection of caspofungin
Time Frame
Day1,day3,day4 after the start of the dosing
Title
Half-Life (t 1/2)
Description
The time of duration from the starting of injection to half plasma concentration of caspofungin
Time Frame
Day1 after the start of the dosing
Title
Area under the plasma concentration versus time curve (AUC)
Description
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 Outcome Measure Information:
Title
The duration of fever
Description
The duration of the fever in patients
Time Frame
7 days after drug withdrawal
Title
Survival rate
Description
The number of surviving patients divided by the total number of patients
Time Frame
7 days after drug withdrawal
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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）
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianda Hu, Ph.D
Organizational Affiliation
Affiliated Concord Hospital of Fujian Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Concord Hospital of Fujian Medical University
City
Fuzhou
State/Province
Fujian
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
The First Affiliated Hospital of Suzhou University
City
Suzhou
State/Province
Jiangsu
Country
China
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
Country
China
Facility Name
Tongji Hospital of Shanghai
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
The First Affiliated Hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
12. IPD Sharing Statement
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Empiric Therapy of Patients With Persistent Fever and Agranulocytosis Using Caspofungin
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