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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Guangzhou General Hospital of Guangzhou Military Command.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Nanfang Hospital of Southern Medical University
First Affiliated Hospital, Sun Yat-Sen University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Renmin Hospital of Zhongshan Guangdong
Southern Medical University zhujiang Hospital
Information provided by:
Guangzhou General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier:
NCT01160952
First received: July 12, 2010
Last updated: July 23, 2010
Last verified: July 2010
  Purpose
  • 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

Condition Intervention Phase
Hematological Diseases
Allogeneic Stem Cell Transplantation
Drug: itraconazole
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Guangzhou General Hospital of Guangzhou Military Command:

Primary Outcome Measures:
  • efficacy evaluation [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    the success rate of prophylaxis therapy by itraconazole


Secondary Outcome Measures:
  • group difference evaluation [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    efficacy difference between long-term and short-term groups per success rate at day 90


Estimated Enrollment: 120
Study Start Date: May 2009
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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.

  Eligibility

Ages Eligible for Study:   14 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01160952

Contacts
Contact: Yonghua Li, MD 8613751880527 lyhood@163.com
Contact: Xiaohui Zeng, Pharm D 8613560327666 gzlcyljd@163.com

Locations
China, Guangdong
Guangzhou General Hospital of Guangzhou Military Command Recruiting
Guangzhou, Guangdong, China, 510010
Contact: Yonghua Li, MD    8613751880527    lyhood@163.com   
Contact: Xiaohui Zeng, Pharm D    8613560327666    gzlcyljd@163.com   
Principal Investigator: Yang Xiao, MD         
Sponsors and Collaborators
Guangzhou General Hospital of Guangzhou Military Command
Nanfang Hospital of Southern Medical University
First Affiliated Hospital, Sun Yat-Sen University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Renmin Hospital of Zhongshan Guangdong
Southern Medical University zhujiang Hospital
Investigators
Principal Investigator: Yang Xiao, MD Guangzhou General Hospital of Guangzhou Military Command
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jian Liu (President of the hospital), Guangzhou General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier: NCT01160952     History of Changes
Other Study ID Numbers: SPO-I-08-CN-041-C, ITRFUN4046
Study First Received: July 12, 2010
Last Updated: July 23, 2010
Health Authority: China: Ethics Committee

Keywords provided by Guangzhou General Hospital of Guangzhou Military Command:
primary prophylaxis
itraconazole
stem cell transplantation

Additional relevant MeSH terms:
Hematologic Diseases
Itraconazole
Hydroxyitraconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014