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Efficacy of Itraconazole as Secondary Prophylaxis in Patients Undergoing Allogeneic Stem Cell Transplantation or Chemotherapy With Prior Invasive Fungal Infection

Phase 4
18 Years
65 Years
Not Enrolling
Invasive Fungal Infection

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Trial Information

Efficacy of Itraconazole as Secondary Prophylaxis in Patients Undergoing Allogeneic Stem Cell Transplantation or Chemotherapy With Prior Invasive Fungal Infection

Inclusion Criteria:

- 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 Criteria:

- 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

- Patients with bad whole body status and not suitable for the trial (doctors make the

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

successful prophylaxis rate

Outcome Description:

The rate of patients without documented relapse of the fungal infection and the absence of new proven, probable or possible IFI at the end of secondary prophylaxis treatment and 7 days later.

Outcome Time Frame:

more than 7 days

Safety Issue:


Principal Investigator

He Huang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The First Hopspital of Zhejiang Medical Colleage, Zhejiang University


China: Food and Drug Administration

Study ID:




Start Date:

July 2008

Completion Date:

November 2010

Related Keywords:

  • Invasive Fungal Infection
  • hematological malignancy
  • previous proven or probable invasive fungal infection
  • Mycoses