Status:
UNKNOWN
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
Lead Sponsor:
Guangzhou General Hospital of Guangzhou Military Command
Collaborating Sponsors:
Nanfang Hospital, Southern Medical University
First Affiliated Hospital, Sun Yat-Sen University
Conditions:
Hematological Diseases
Allogeneic Stem Cell Transplantation
Eligibility:
All Genders
14-60 years
Phase:
PHASE2
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 lo...
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 int...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2011
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01160952
Start Date
May 1 2009
End Date
March 1 2011
Last Update
July 26 2010
Active Locations (1)
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1
Guangzhou General Hospital of Guangzhou Military Command
Guangzhou, Guangdong, China, 510010