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

July 23, 2010 updated by: Guangzhou General Hospital of Guangzhou Military Command
  • 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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Invasive fungal infections (IFI) remain the major cause of death among neutropenic patients receiving high dose chemotherapy or allo-SCT. Especially, patients undergoing allo-SCT generally receive intensive immunosuppressive therapy, which make those patients at high risk of developing IFI.

Prompt intensive antifungal therapy may increase the incidence rate of IFI and improved responses and survival. Antifungal prophylaxis has been recommended in patients undergoing allo-SCT by Infectious diseases society of America (IDSA) and Chinese guidelines for the diagnosis and management of IFI in patients with hematologic/malignant tumor (revised).

Few studies have addressed the role of previous IFI in the feasibility of stem cell transplant, or the secondary prophylaxis with antifungal drugs in preventing recurrence of infection after transplantation. However, given the lack of prospective studies, the role of primary antifungal prevention and the course of treatment remain unclear.

Itraconazole is a wide-spectrum triazole antifungal agent active against Candida albicans, non-albicans, Aspergillus spp., Blastomyces dermatitidis, Blastomyces coccidioides, Cryptococcus neoformans, Sporothrix schenkii, Paracoccidioides brasiliensis, Histoplasma spp. and various kinds of yeast fungi and mycetes.

The role of itraconazole in IFI prophylaxis has been proved by many interventional studies. However the optimal course of prophylaxis is still unknown，especially in China. In this prospective, multicentric study of primary antifungal prevention, long-term or short-term sequential therapy (intravenous followed by oral itraconazole) will be given at standard dose to patients undergoing allogeneic stem cell transplantation to assess the efficacy and safety of itraconazole in primary prophylaxis, and to analysis the relationship between the incidence rate of IFI with plasma concentrations of itraconazole and hydroxy-itraconazole.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yonghua Li, MD
  • Phone Number: 8613751880527
  • Email: lyhood@163.com

Study Contact Backup

  • Name: Xiaohui Zeng, Pharm D
  • Phone Number: 8613560327666
  • Email: gzlcyljd@163.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510010
        • Recruiting
        • Guangzhou General Hospital of Guangzhou Military Command
        • Principal Investigator:
          • Yang Xiao, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Man or woman between 14 and 60 years of age, inclusive
  • Patients who affected by hematological diseases, receiving allo-SCT
  • Patients with no previous proven or probable invasive fungal infections. Patients without microbiological evidence but with effective anti-fungal therapy history are inclusive
  • Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria:

  • Currently taking the contra-indicated medications such as teldane, astemizol, cisapride and HMG-CoA reductase inhibitor（e.g. Simvastatin, lovastatin, oral Midazolam and Triazolam）
  • History of allergy or intolerance to imidazole or azoles anti-fungal agents (e.g. Fluconazol, Itraconazole, Ketoconazole, Miconazole, Clotrimazole)
  • Pregnant women, lactating women or women of child bearing potential without applying valid contraceptive measures
  • Patients with current cardiac dysfunction (especially with congestive heart failure) or with the history of congestive heart failure
  • Patients with severe liver dysfunction (aminotransferase levels >= 5 times the upper limit of normal and total bilirubin level >= 3mg/dL(51.3 μmol/L); or the severity of liver dysfunction does not match this criteria but the patient is in bad condition and not suitable for this trial( doctors make the decision);
  • Patients with renal insufficiency having serum Ccr level <30ml/min, calculated from the following formula:

Male: Ccr (ml/min)=(140-age)×weight (kg) /(0.8136×Crea (μmol/L) ) Female:Ccr (ml/min)=(140-age)×weight (kg) ×0.85/(0.8136× Crea (μmol/L) )

  • Patients received any experimental drug within 14 days before the planned start of treatment.
  • Patients with bad whole body status and not suitable for the trial (doctors make the decision)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: long-term group
long-term group refers to prophylaxis by using itraconazole for up to 90 days
Drug: itraconazole
the two groups are defined by different treatment duration
Other: short term group
short term group refers to prophylaxis by itraconazole for 30 days
Drug: itraconazole
the two groups are defined by different treatment duration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
efficacy evaluation
Time Frame: 90 days
the success rate of prophylaxis therapy by itraconazole
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
group difference evaluation
Time Frame: 90 days
efficacy difference between long-term and short-term groups per success rate at day 90
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou General Hospital of Guangzhou Military Command

Collaborators

First Affiliated Hospital, Sun Yat-Sen University
Nanfang Hospital of Southern Medical University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Zhujiang Hospital
Renmin Hospital of Zhongshan Guangdong

Investigators

  • Principal Investigator: Yang Xiao, MD, Guangzhou General Hospital of Guangzhou Military Command

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

March 1, 2011

Study Registration Dates

First Submitted

July 12, 2010

First Submitted That Met QC Criteria

July 12, 2010

First Posted (Estimate)

July 13, 2010

Study Record Updates

Last Update Posted (Estimate)

July 26, 2010

Last Update Submitted That Met QC Criteria

July 23, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPO-I-08-CN-041-C
  • ITRFUN4046 (Other Grant/Funding Number: Xi'an Janssen pharmaceutical Ltd.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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