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Status unknownNCT01160952Updated Jul 26, 2010

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

A Phase 2 interventional study of itraconazole in Hematological Diseases and Allogeneic Stem Cell Transplantation, sponsored by Guangzhou General Hospital of Guangzhou Military Command. Status unknown at 1 site in China. Open to participants aged 14 Years to 60 Years. Per ClinicalTrials.gov, last updated 2010-07-26.

Sponsored by Guangzhou General Hospital of Guangzhou Military Command · Phase 2, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jul 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
14 Years to 60 Years
Sex
All
01

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
Read the 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.

02

Conditions studied

  • Hematological Diseases
  • Allogeneic Stem Cell Transplantation

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Keywords

  • primary prophylaxis
  • itraconazole
  • stem cell transplantation
03

In context

Hematologic Diseases

459 studies on the registry are indexed under Hematologic Diseases; 105 are open to participants now.

This study's planned enrollment of 120 is above the median of 50 across 273 interventional studies indexed under Hematologic Diseases.

Browse Hematologic Diseases studies →

Lead sponsor

Guangzhou General Hospital of Guangzhou Military Command is the lead sponsor of 46 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Other
    long-term group

    long-term group refers to prophylaxis by using itraconazole for up to 90 days

    Drug: itraconazole

  • Other
    short term group

    short term group refers to prophylaxis by itraconazole for 30 days

    Drug: itraconazole

Interventions

  • Drugitraconazole

    the two groups are defined by different treatment duration

06

What researchers measure

Primary outcomes

  1. efficacy evaluation

    the success rate of prophylaxis therapy by itraconazole

    Time frame: 90 days

Secondary outcomes

  1. group difference evaluation

    efficacy difference between long-term and short-term groups per success rate at day 90

    Time frame: 90 days

07

Study locations

1 of 1 sites recruiting
  • Guangzhou General Hospital of Guangzhou Military Command
    Guangzhou, Guangdong 510010, China
    • Yonghua Li, MD · Contact · lyhood@163.com · 8613751880527
    • Xiaohui Zeng, Pharm D · Contact · gzlcyljd@163.com · 8613560327666
    • Yang Xiao, MD · Principal investigator
    Recruiting
08

References and documents

Publications

  • Marr KA, Crippa F, Leisenring W, Hoyle M, Boeckh M, Balajee SA, Nichols WG, Musher B, Corey L. Itraconazole versus fluconazole for prevention of fungal infections in patients receiving allogeneic stem cell transplants. Blood. 2004 Feb 15;103(4):1527-33. doi: 10.1182/blood-2003-08-2644. Epub 2003 Oct 2. PubMed 14525770 ↗
  • Winston DJ, Maziarz RT, Chandrasekar PH, Lazarus HM, Goldman M, Blumer JL, Leitz GJ, Territo MC. Intravenous and oral itraconazole versus intravenous and oral fluconazole for long-term antifungal prophylaxis in allogeneic hematopoietic stem-cell transplant recipients. A multicenter, randomized trial. Ann Intern Med. 2003 May 6;138(9):705-13. doi: 10.7326/0003-4819-138-9-200305060-00006. PubMed 12729424 ↗
  • Chinese guideline for the diagnosis and management of IFI in patients with hematologic/maliglant tumor (revised). Chinese journal of internal medicine 2007，46(7):607-610.
  • Lin R, Xu X, Li Y, Sun J, Fan Z, Jiang Q, Huang F, Zhou H, Nie D, Guo Z, Mao Y, Xiao Y, Liu Q. Comparison of long-term and short-term administration of itraconazole for primary antifungal prophylaxis in recipients of allogeneic hematopoietic stem cell transplantation: a multicenter, randomized, open-label trial. Transpl Infect Dis. 2014 Apr;16(2):286-94. doi: 10.1111/tid.12192. Epub 2014 Mar 5. PubMed 24593273 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 26, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01160952
Lead sponsor
Guangzhou General Hospital of Guangzhou Military Command
Collaborators
Nanfang Hospital, 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, Zhujiang Hospital
First posted
Jul 13, 2010
Start date
May 2009
Primary completion
Dec 2010 (estimated)
Completion
Mar 2011 (estimated)
Last update
Jul 26, 2010

Study contacts

Yonghua Li, MD
Contact
lyhood@163.com
8613751880527
Xiaohui Zeng, Pharm D
Contact
gzlcyljd@163.com
8613560327666
Yang Xiao, MD
principal investigator · Guangzhou General Hospital of Guangzhou Military Command

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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