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

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

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-26

Study Completion Date

2015-08-28

Brief Summary

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

To evaluate the efficacy and safety of intravenous micafungin for the treatment of patients with proven or probable fungal infections caused by Candida 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

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

NCT02646774

Invasive Aspergillosis

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

Study of Micafungin in Patients With Invasive Candidiasis or Candidemia

NCT00105144

Candidiasis Candidemia

COMPLETED PHASE3

Micafungin Versus Fluconazole in the Treatment of Invasive Candidiasis and Candidemia

NCT00189709

Invasive 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.

Candidemia Candidiasis

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.

Treatment group

Intravenous (IV)

Group Type EXPERIMENTAL

Micafungin

Intervention Type DRUG

Intravenous (IV)

Interventions

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

Micafungin

Intravenous (IV)

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* The diagnosis criteria of probable candida infection: Risk factors + Clinical Manifestations + positive findings including microbiologic test
* The diagnosis criteria of proven candida infection: Risk factors + Clinical Manifestation + positive findings including microbiologic test + tissue culture or pathological examination results
* The following 3 criteria must be met is a patient is diagnosed as probable candida pneumonia:

1. Risk factor (s) of infection
2. Clinical manifestations of infection and the pulmonary infection cannot be explained by other pathogenic infections
3. Two or more positive sputum culture for Candida

Exclusion Criteria

* Patient received any other antifungal drug within 1 month prior to enrollment.
* HIV positive patient
* Patients with organ transplant
* Patients with agranulocytosis

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No