Fungal InfectionPhase 2NCT03857399

Empiric Therapy of Patients With Persistent Fever and Agranulocytosis Using Caspofungin

A Phase 2 study testing Caspofungin in people with Fungal Infection, run by Cttq at 6 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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… Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Fungal Infection
What is being tested?: Caspofungin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 6 sitesChina
Study dates: 17 Sep 2018to 31 Dec 2019
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 9Show fewer

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）

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

China6 sites

Affiliated Concord Hospital of Fujian Medical University
Fuzhou, Fujian
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang
Qilu Hospital of Shandong University
Jinan, Shandong
Jiangsu Province Hospital
Nanjing, Jiangsu
Tongji Hospital of Shanghai
Shanghai, Shanghai Municipality
The First Affiliated Hospital of Suzhou University
Suzhou, Jiangsu

Other trials in China

About this study

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

Read the 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.

Conditions: Fungal Infection
Being tested: Caspofungin
Medical subject headings: Mycoses

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03857399
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Caspofungin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 7 days after drug withdrawal
Peak Plasma Concentration (Cmax)
The peak plasma concentration after injection of caspofungin
Measured: 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
Measured: 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
Measured: Day1,day3,day4 after the start of the study

Secondary outcomes (2)

The duration of fever
The duration of the fever in patients
Measured: 7 days after drug withdrawal
Survival rate
The number of surviving patients divided by the total number of patients
Measured: 7 days after drug withdrawal

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Sep 201831 Dec 2019

First posted28 Feb 2019
Study start17 Sep 2018
Primary completion31 Dec 2019
Study completion31 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Fungal InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03857399
Sponsor's protocol ID: CTTQ-CORE-101
Status last verified: Dec 2020
First submitted: 16 Nov 2018
Last updated: 7 Jul 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Fungal Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03857399
Acronym / sponsor ID: CTTQ-CORE-101
Conditions: Fungal Infection
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: CttqIndustry (pharma, biotech, devices)
Study start: 17 Sep 2018 (actual)
Primary completion: 31 Dec 2019 (actual)
Study completion: 31 Dec 2019 (actual)
First posted: 28 Feb 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm-1	Experimental	Drug: CaspofunginPatients 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-2	Active comparator	Drug: CaspofunginPatients will be assigned to receive intravenous original caspofungin (70 mg on day 1 and 50 mg once daily),the therapeutical duration is 4 Days.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (9 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CaspofunginAlso: original caspofunginConsidering the possibility of fungal infection, we take empiric therapy for the patients with persistent fever and agranulocytosis using caspofungin for injection.	Drug	Arm-1, Arm-2

Primary outcome

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

2 secondary outcomes

The duration of fever
Time frame: 7 days after drug withdrawal
Survival rate
Time frame: 7 days after drug withdrawal

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.

Related trials for Fungal Infection

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Hidradenitis Suppurativa (HS)
Active, not recruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jianda Hu, Ph.D principal investigator

Affiliated Concord Hospital of Fujian Medical University

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Caspofungin in people with Fungal Infection, run by Cttq at 6 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy evaluation 7 days after drug withdrawal (time frame: 7 days after drug withdrawal). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03857399.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021.