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

NCT01160952 | Unknown Phase 2 DMC

• 2 other identifiers: SPO-I-08-CN-041-CITRFUN4046
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Hematological Diseases; Allogeneic Stem Cell Transplantation

Keywords

primary prophylaxis; itraconazole; stem cell transplantation

Outcome Measures

Primary Outcomes (1)

• efficacy evaluation

  the success rate of prophylaxis therapy by itraconazole

  90 days

Secondary Outcomes (1)

• group difference evaluation

  90 days

Study Arms (2)

long-term group

OTHER

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

Drug: itraconazole

short term group

OTHER

short term group refers to prophylaxis by itraconazole for 30 days

Drug: itraconazole

Interventions

itraconazole DRUG

the two groups are defined by different treatment duration

long-term group; short term group

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Guangzhou General Hospital of Guangzhou Military Command: lead
• Nanfang Hospital, Southern Medical University: collaborator
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator
• Renmin Hospital of Zhongshan Guangdong: collaborator
• Zhujiang Hospital: collaborator

Study Sites (1)

Guangzhou General Hospital of Guangzhou Military Command

Guangzhou, Guangdong, 510010, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 14525770 BACKGROUND

• 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.

  PMID: 12729424 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.

  BACKGROUND

• 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.

  PMID: 24593273 DERIVED

MeSH Terms

Conditions

Hematologic Diseases

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Yang Xiao, MD

  Guangzhou General Hospital of Guangzhou Military Command

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yonghua Li, MD

CONTACT

8613751880527; lyhood@163.com

Xiaohui Zeng, Pharm D

CONTACT

8613560327666; gzlcyljd@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 12, 2010
• First Posted: July 13, 2010
• Study Start: May 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: March 1, 2011
• Last Updated: July 26, 2010

Record last verified: 2010-07

Locations

CN (1)