Post Marketing Study to Evaluate the Efficacy and Safety of Micafungin Treatment on Invasive Aspergillosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-01

Study Completion Date

2015-06-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of this study is to evaluate the efficacy and safety of intravenous micafungin for the treatment of proven or probable fungal infections caused by Aspergillus sp. (Fungemia, respiratory mycosis, gastrointestinal mycosis) in adult patients in China.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Post Marketing Study to Evaluate the Safety and Efficacy of Micafungin Against Fungal Infections Caused by Candida Spp or Aspergillus Spp

NCT02646800

Aspergillosis Candidiasis

TERMINATED PHASE4

A Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Candidiasis or Candidemia

NCT01982071

Candidemia Candidiasis

TERMINATED PHASE4

A Retrospective Study Evaluating the Efficacy and Safety of Micafungin Sodium in the Treatment of Invasive Fungal Infections

NCT02678598

Invasive Fungal Infections

COMPLETED

Micafungin Salvage Mono-therapy in Invasive Aspergillosis

NCT00376337

Invasive Aspergillosis

TERMINATED PHASE2

Study of Micafungin in Patients With Invasive Candidiasis or Candidemia

NCT00105144

Candidiasis Candidemia

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Invasive Aspergillosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Micafungin group

Injection

Group Type EXPERIMENTAL

Micafungin

Intervention Type DRUG

Injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Micafungin

Injection

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients who are diagnosed as proven or probable infections caused by aspergillus (including fungemia, respiratory mycosis and gastrointestinal mycosis) with reference to the definition of EORTC/MSG
* Females of childbearing potential are not pregnant in the study and reliable methods of contraception should be maintained during the whole study.
* Patients capable to understand the purposes and risks of the study, who are willing and able to participate in the study and from whom written and dated informed consent to participate in the study is obtained.

Exclusion Criteria

* Patient received any echinocandins drug within 1 month prior to enrollment.
* Patient was enrolled in any other clinical study within the last month.
* AST/ALT \> 5 times the upper limit of normal (ULN)
* total bilirubin\> 2.5 times ULN
* BUN/Ccr \> 3 times ULN
* HIV positive patient
* Patient has a history of hypersensitivity, or any serious reaction to any component of this product or other echinocandins.
* Patient has a life expectancy of \<1 month
* Subject is unlikely to comply with the visits scheduled in the protocol in the opinion of investigator or has a history of non-compliance.
* Pregnant women, nursing mothers, lactating women, and women of child-bearing potential who are unwilling to use reliable contraception for the duration of the study and for 6 weeks following completion of the study.
* Patient has been previously enrolled in this study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No