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A Study to Compare Efficacy and Safety of Mycamine® and Itraconazole for Preventing Fungal Infections

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Fungemia; Fungal Infections

Intervention: micafungin (Mycamine) (Drug); itraconazole (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Use Central Contact, Study Chair, Affiliation: Astellas Pharma Inc

Summary

The objective of this study is to compare the efficacy and safety between Mycamine and Itraconazole oral solution in preventing invasive fungal infections on autologous(malignant blood diseases) or allogeneic hematopoietic stem cell transplant patients

Clinical Details

Official title: A Multi-center, Randomized, Open Label, Parallel Study to Evaluate and Compare the Efficacy and Safety of Mycamine« vs Itraconazole Oral Solution for Prophylaxis of Fungal Infections in Patients Undergoing a Hematopoietic Stem Cell Transplant

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Treatment success rate (fungal breakthrough rate)

Secondary outcome:

Incidence of proven or probable invasive fungal infection

The usage rate of systemic antifungal agents

Time to treatment failure

Assessment of Adverse events, Laboratory examinations and vital signs evaluation

Detailed description: Dosing of Mycamine or Itraconazole will start at the beginning of the transplant conditioning regimen or within 48 hours after the transplant conditioning regimen, and administration time should be no longer than 42 days

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients at risk of systemic fungal infections due to their immunocompromised state

due to one of the following:

- Patient with a hematologic malignancy undergoing an autologous hematopoietic

stem cell transplant

- Any patient undergoing an allogeneic hematopoietic stem cell transplant

Exclusion Criteria:

- Patients with moderate or severe liver disease, as defined by:

- AST or ALT greater than 5 times upper limit of normal (ULN), OR;

- Total bilirubin greater than 2. 5 times ULN

- Patients with evidence of a deeply invasive or disseminated fungal infection at time

of enrollment

Locations and Contacts

Jiangsu, China

Nanning, China

Peking, China

Shanghai, China

Tianjin, China

Xian, China

Fuzhou, Fujian, China

Wuhan, Hubei, China

Chengdu, Sichuan, China

Hangzhou, Zhejiang, China

Additional Information

Starting date: November 2008
Last updated: February 8, 2010

Page last updated: August 23, 2015

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