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Empiric Therapy of Patients With Persistent Fever and Agranulocytosis Using Caspofungin

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ClinicalTrials.gov Identifier: NCT03857399
Recruitment Status : Completed
First Posted : February 28, 2019
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
Cttq

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.

Condition or disease Intervention/treatment Phase
Fungal Infection Drug: Caspofungin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 17, 2018
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: Caspofungin
Considering the possibility of fungal infection, we take empiric therapy for the patients with persistent fever and agranulocytosis using caspofungin for injection.
Other Name: original caspofungin

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




Primary Outcome Measures :
  1. Efficacy evaluation 7 days after drug withdrawal [ Time Frame: 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.

  2. Peak Plasma Concentration (Cmax) [ Time Frame: Day1,day3,day4 after the start of the dosing ]
    The peak plasma concentration after injection of caspofungin

  3. Half-Life (t 1/2) [ Time Frame: Day1 after the start of the dosing ]
    The time of duration from the starting of injection to half plasma concentration of caspofungin

  4. Area under the plasma concentration versus time curve (AUC) [ Time Frame: Day1,day3,day4 after the start of the study ]
    The area under the plasma concentration of caspofungin versus time curve from Day1 to Day4 after the fist dosing


Secondary Outcome Measures :
  1. The duration of fever [ Time Frame: 7 days after drug withdrawal ]
    The duration of the fever in patients

  2. Survival rate [ Time Frame: 7 days after drug withdrawal ]
    The number of surviving patients divided by the total number of patients



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03857399


Locations
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China, Fujian
Affiliated Concord Hospital of Fujian Medical University
Fuzhou, Fujian, China
China, Jiangsu
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Suzhou University
Suzhou, Jiangsu, China
China, Shandong
Qilu Hospital of Shandong University
Jinan, Shandong, China
China, Shanghai
Tongji Hospital of Shanghai
Shanghai, Shanghai, China
China, Zhejiang
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
Sponsors and Collaborators
Cttq
Investigators
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Principal Investigator: Jianda Hu, Ph.D Affiliated Concord Hospital of Fujian Medical University
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Responsible Party: Cttq
ClinicalTrials.gov Identifier: NCT03857399    
Other Study ID Numbers: CTTQ-CORE-101
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020

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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
Additional relevant MeSH terms:
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Mycoses
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Caspofungin
Antifungal Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action