Clinical Trials Logo
  1. Home
  2. Fungal Infection
  3. NCT03857399

Empiric Therapy of Patients With Persistent Fever and Agranulocytosis Using Caspofungin

Fungal Infection Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03857399
Study type Interventional
Source Cttq
Contact
Status Completed
Phase Phase 2
Start date September 17, 2018
Completion date December 31, 2019
View Details
See also
  Status Clinical Trial Phase
Completed NCT03641131 - Ampholipad Real-World Data in Taiwan
Not yet recruiting NCT03292224 - Systemic Fungal Infections in ICU Patients N/A
Completed NCT01371656 - Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation Phase 3
Completed NCT00936117 - Pharmacokinetics of Posaconazole Prophylaxis in Acute Leukemia Phase 2
Completed NCT00740389 - TMC125-TiDP2-C187: A Phase I, Open-label Trial to Investigate the Pharmacokinetic Interaction Between TMC125 and Two Antifungal Agents (Fluconazole and Voriconazole), All at Steady-state in Healthy Subjects. Phase 1
Not yet recruiting NCT04215458 - Microbiota in Skin and Mucosa of Patients With Inflammatory Skin Diseases N/A
Completed NCT03667690 - Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis Phase 3
Completed NCT02957929 - Safety, Pharmacokinetics, Bioavailability, Food Effect, Drug-Drug Interaction Study of APX001 Administered Orally Phase 1
Completed NCT01419678 - Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients N/A
Recruiting NCT00333645 - Prophylaxis With Caspofungin in High-Risk Liver Transplantation Phase 2
Not yet recruiting NCT03650439 - Fungal Infections in Patients With Hematological Malignancies
Completed NCT01303549 - Anidulafungin vs Amphotericin B Safety in High Risk Hepatic Transplant Recipients Phase 4
Completed NCT00811642 - Posaconazole Treatment of Invasive Fungal Infection (IFI) (P05551) Phase 3
Withdrawn NCT00430469 - Safety of hLF1-11 for the Treatment of Infectious Complications Among HSCT Recipients Phase 1/Phase 2
Terminated NCT00386997 - ProphyALL - Study on the Safety of Liposomal Amphotericin B to Prevent Antifungal Infections in Elderly Patients With Acute Lymphoblastic Leukemia Phase 4
Completed NCT00514358 - Fluconazole Pharmacokinetics in Infants Phase 1
Completed NCT04166669 - A Drug-Drug Interaction Study of CYP3A4 Inhibition and Pan-CYP Induction on APX001 Phase 1
Recruiting NCT05150327 - Multicenter Cohort Study of Invasive Fungal Filamentous Fungal Infections in Liver Transplant Patients
Completed NCT02387983 - Pharmacokinetics and Safety of Oral Posaconazole (MK-5592)Tablets in Chinese Participants at High Risk for Invasive Fungal Infections (MK-5592-117) Phase 1
Completed NCT02956499 - Study to Assess Safety, Tolerability and Pharmacokinetics of APX001 Administered by Intravenous Infusion to Healthy Subjects Phase 1