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| ID | Type | Description | Link |
|---|---|---|---|
| ITRFUN4046 | Other Grant/Funding Number | Xi'an Janssen pharmaceutical Ltd. |
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| Name | Class |
|---|---|
| Nanfang Hospital, Southern Medical University | OTHER |
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| long-term group | Other | long-term group refers to prophylaxis by using itraconazole for up to 90 days |
|
| short term group | Other | short term group refers to prophylaxis by itraconazole for 30 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| itraconazole | Drug | the two groups are defined by different treatment duration |
|
| Measure | Description | Time Frame |
|---|---|---|
| efficacy evaluation | the success rate of prophylaxis therapy by itraconazole | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| group difference evaluation | efficacy difference between long-term and short-term groups per success rate at day 90 | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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) )
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yonghua Li, MD | Contact | 8613751880527 | lyhood@163.com | |
| Xiaohui Zeng, Pharm D | Contact | 8613560327666 | gzlcyljd@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yang Xiao, MD | Guangzhou General Hospital of Guangzhou Military Command | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou General Hospital of Guangzhou Military Command | Recruiting | Guangzhou | Guangdong | 510010 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14525770 | Background | 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. | |
| 12729424 | Background |
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| Renmin Hospital of Zhongshan Guangdong |
| UNKNOWN |
| Zhujiang Hospital | OTHER |
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| 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. |
| Background | 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. |
| 24593273 | Derived | 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. |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| ID | Term |
|---|---|
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
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