Clinical trial NCT00794703: A Study to Compare Efficacy and Safety of Mycamine® and Itraconazole for Preventing Fungal Infections
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fungemia
Fungal Infections
Keywords: Antifungal
micafungin
itraconazole
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2008-11-20
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

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 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

Primary outcomes:
measure: Treatment success rate (fungal breakthrough rate)
timeFrame: At the end of the study
Secondary outcomes:
measure: Incidence of proven or probable invasive fungal infection
timeFrame: Throughout the study period
measure: The usage rate of systemic antifungal agents
timeFrame: During 4 weeks after the administration
measure: Time to treatment failure
timeFrame: During the study period
measure: Assessment of Adverse events, Laboratory examinations and vital signs evaluation
timeFrame: Throughout the study period
Other outcomes:
Locations:
city: Fuzhou
country: China
state: Fujian
city: Wuhan
country: China
state: Hubei
city: Chengdu
country: China
state: Sichuan
city: Hangzhou
country: China
state: Zhejiang
city: Jiangsu
country: China
city: Nanning
country: China
city: Peking
country: China
city: Shanghai
country: China
city: Tianjin
country: China
city: Xian
country: China
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
citation: Huang X, Chen H, Han M, Zou P, Wu D, Lai Y, Huang H, Chen X, Liu T, Zhu H, Wang J, Hu J. Multicenter, randomized, open-label study comparing the efficacy and safety of micafungin versus itraconazole for prophylaxis of invasive fungal infections in patients undergoing hematopoietic stem cell transplant. Biol Blood Marrow Transplant. 2012 Oct;18(10):1509-16. doi: 10.1016/j.bbmt.2012.03.014. Epub 2012 Mar 30.