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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm-1 | Experimental | 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. |
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| Arm-2 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caspofungin | Drug | Considering the possibility of fungal infection, we take empiric therapy for the patients with persistent fever and agranulocytosis using caspofungin for injection. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Peak Plasma Concentration (Cmax) | The peak plasma concentration after injection of caspofungin | Day1,day3,day4 after the start of the dosing |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The duration of fever | The duration of the fever in patients | 7 days after drug withdrawal |
| Survival rate | The number of surviving patients divided by the total number of patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianda Hu, Ph.D | Affiliated Concord Hospital of Fujian Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Concord Hospital of Fujian Medical University | Fuzhou | Fujian | China | |||
| Jiangsu Province Hospital |
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| ID | Term |
|---|---|
| D009181 | Mycoses |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077336 | Caspofungin |
| ID | Term |
|---|---|
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| 7 days after drug withdrawal |
| 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 |
| D054714 |
| Echinocandins |
| D010456 | Peptides, Cyclic |