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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01160952
Other study ID # SPO-I-08-CN-041-C
Secondary ID ITRFUN4046
Status Recruiting
Phase Phase 2
First received July 12, 2010
Last updated July 23, 2010
Start date May 2009
Est. completion date March 2011

Study information

Verified date July 2010
Source Guangzhou General Hospital of Guangzhou Military Command
Contact Yonghua Li, MD
Phone 8613751880527
Email lyhood@163.com
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial 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


Description:

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Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
itraconazole
the two groups are defined by different treatment duration

Locations

Country Name City State
China Guangzhou General Hospital of Guangzhou Military Command Guangzhou Guangdong

Sponsors (6)

Lead Sponsor Collaborator
Guangzhou General Hospital of Guangzhou Military Command First Affiliated Hospital, Sun Yat-Sen University, Nanfang Hospital of Southern Medical University, Renmin Hospital of Zhongshan Guangdong, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Zhujiang Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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.

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. Epub 2003 Oct 2. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary efficacy evaluation the success rate of prophylaxis therapy by itraconazole 90 days No
Secondary group difference evaluation efficacy difference between long-term and short-term groups per success rate at day 90 90 days No
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