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Long-term Versus Short-term Sequential Therapy (Intravenous Itraconazole Followed by Oral Solution) of Itraconazole as Primary Prophylaxis in Patients Undergoing Allogeneic Stem Cell Transplantation

NCT01160952 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2010-07-26

No results posted yet for this study

Summary

* The primary objective of this study is to evaluate the efficacy and safety profile of itraconazole as in primary prophylaxis
* The second objective of this study is to find the difference between long-term versus short-term sequential therapy of Itraconazole (intravenous followed by oral itraconazole) as primary prophylaxis of invasive fungal infections (IFI) in patients undergoing allogeneic stem cell transplantation (allo-SCT)
* also to explore the relationship between the incidence of IFI with plasma concentrations of itraconazole and hydroxy-itraconazole

Conditions

  • Hematological Diseases
  • Allogeneic Stem Cell Transplantation

Interventions

DRUG

itraconazole

the two groups are defined by different treatment duration

Sponsors & Collaborators

  • Nanfang Hospital, Southern Medical University

    collaborator OTHER

  • First Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    collaborator OTHER

  • Renmin Hospital of Zhongshan Guangdong

    collaborator UNKNOWN

  • Zhujiang Hospital

    collaborator OTHER

  • Guangzhou General Hospital of Guangzhou Military Command

    lead OTHER

Principal Investigators

  • Yang Xiao, MD · Guangzhou General Hospital of Guangzhou Military Command

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2010-12-31
Completion
2011-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01160952 on ClinicalTrials.gov