Status:
COMPLETED
Efficacy of Itraconazole as Secondary Prophylaxis in Patients Undergoing Allogeneic Stem Cell Transplantation or Chemotherapy With Prior Invasive Fungal Infection
Lead Sponsor:
Zhejiang University
Collaborating Sponsors:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Zhejiang Provincial Hospital of TCM
Conditions:
Invasive Fungal Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Invasive fungal infections (IFI) remain the major cause of death among neutropenic patients receiving chemotherapy for leukemia, or submitted to stem cell transplantation. Patients with a history of i...
Eligibility Criteria
Inclusion
- Man or woman between 18 and 65 years of age, inclusive.
- Patients who affected by hematological malignancies, receiving chemotherapy, or submitted to stem cell transplantation.
- Patients with previous proven or probable invasive fungal infections, with residual or absent lesions on CT scan or X-ray and the absence of clinical signs of fungal infection at the time of enrollment. Or, possible IFI patients without microbiological evidence but with effective anti-fungal therapy history.
- (The diagnosis is according to the definitions of Chinese guideline for the diagnosis and treatment of invasive fungal infections in immunocompromised patients with cancer cancer and hematopoietic stem cell transplant.)
- 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.
- Lack of clinical symptoms of invasive fungal infection
Exclusion
- Patient has no response to the previous intravenous itraconazole antifungal therapy.
- Currently taking the contra-indicated medications such as teldane, astemizol, cisapride and HMG-CoA reductase inhibitor（e.g. Simvastatin, ovastatin, 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 10 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 :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01198236
Start Date
July 1 2008
End Date
November 1 2010
Last Update
October 14 2011
Active Locations (1)
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1
The First Hospital of Zhejiang Medical Colleage Zhejiang University
Hangzhou, Zhejiang, China, 310003