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NCT01982071 Clinical Trial

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

Candidiasis Clinical Trial

Official title:
A Multi-center, Open-label, Non-comparative Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Candidiasis or Candidemia (CFDA Commitment)

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01982071
Other study ID # ACN-MA-MYC-IC-2012
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date September 26, 2013
Est. completion date August 28, 2015

Study information
Verified date December 2018
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Terminated
Enrollment 59
Est. completion date August 28, 2015
Est. primary completion date August 28, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Micafungin
Intravenous (IV)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Astellas Pharma China, Inc.

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall success rate success rate is calculated as (number of success patients/number of patients for efficacy evaluation × 100% at end of treatment) up to 8 weeks
Secondary Safety assessed by the incidence of adverse events up to 10 weeks
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Completed NCT00734539 - Fluconazole Prophylaxis for the Prevention of Candidiasis in Infants Less Than 750 Grams Birthweight Phase 3
Completed NCT00001937 - Comparing the Effectiveness of Fluconazole and a New Medicine (FK463) in Preventing Fungal Infections in Bone Marrow Transplant Patients Phase 3
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