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OpenTrials
Completed

NCT Number: NCT00794703

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

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

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Key information

Conditions

Fungemia Bacterial Infections and Mycoses Fungal Infections Infections Inflammation Invasive Fungal Infections Mycoses Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fuzhou, Fujian, China

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

micafungin (Mycamine)

Drug

Intravenous

Other names: Mycamine, FK463

Itraconazole

Drug

oral

Other names: Sporanox

Primary outcomes

  1. Treatment success rate (fungal breakthrough rate)

    Time frame: At the end of the study

Secondary outcomes

  1. Incidence of proven or probable invasive fungal infection

    Time frame: Throughout the study period

  2. The usage rate of systemic antifungal agents

    Time frame: During 4 weeks after the administration

  3. Time to treatment failure

    Time frame: During the study period

  4. Assessment of Adverse events, Laboratory examinations and vital signs evaluation

    Time frame: Throughout the study period

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 20, 2008
Registry last updated
Mar 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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