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

• Status: Unknown status
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guangzhou General Hospital of Guangzhou Military Command
• Collaborators: 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
• Treatments: Hydroxyitraconazole; Itraconazole

Criteria

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:

• 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)