Empiric Therapy of Patients With Persistent Fever and Agranulocytosis Using Caspofungin

NCT03857399 | Completed Phase 2

• 1 other identifier: CTTQ-CORE-101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 6

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.

Conditions

Fungal Infection

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (2)

• The duration of fever

  7 days after drug withdrawal

• Survival rate

  7 days after drug withdrawal

Study Arms (2)

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.

Drug: Caspofungin

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.

Drug: Caspofungin

Interventions

Caspofungin DRUG

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

Also known as: original caspofungin

Arm-1; Arm-2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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）

Sponsors & Collaborators

• Cttq: lead

Study Sites (6)

Affiliated Concord Hospital of Fujian Medical University

Fuzhou, Fujian, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Location

The First Affiliated Hospital of Suzhou University

Suzhou, Jiangsu, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, China

Location

Tongji Hospital of Shanghai

Shanghai, Shanghai Municipality, China

Location

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Mycoses

Interventions

Caspofungin

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Echinocandins; Peptides, Cyclic

Study Officials

• Jianda Hu, Ph.D

  Affiliated Concord Hospital of Fujian Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: February 28, 2019
• Study Start: September 17, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: July 7, 2021

Record last verified: 2020-12

Locations

CN (6)