Efficacy of itraconazole for invasive fungal infection prophylaxis after induction chemotherapy in acute myeloid leukemia patients
Phase 3
Recruiting
- Conditions
- acute myeloid leukemiainduction chemotherapyinvasive fungal infectionprophylaxisitraconazoleAMLacute myeoloid leukemiaIFIinvasive fungal infectionprophylaxisitraconazole
- Registration Number
- TCTR20160113001
- Lead Sponsor
- siriraj oncology foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 132
Inclusion Criteria
- age 15 year-old or older
- newly diagnosed or relapsed acute myeloid leukemia
- recieved induction chemotherapy treatment included 7+3 regimen, 5+2 regimen, MEC, FLAG, FLAG-ida or Clofarabine
- serum SGOT and SGPT not exceed 2-folds of upper normal limit
- creatnin clearance not lower than 50 mg/min
- informed consent
Exclusion Criteria
- history of allergy to itraconazole
- pregnant
- recently diagnosed invasive fungal infection and recieved antifungal medications within 7 days
- indicated to recieved other definite antifungal treatment
- co-treatment with medications that have major drug interaction with itraconazole for examples: simvastatin, ergot alkaloids
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method invasive fungal infection incidence day 42 of induction chemotherapy descriptive analysis
- Secondary Outcome Measures
Name Time Method mortality rate day 42 of induction chemotherapy descriptive analysis