acute myeloid leukemia induction chemotherapy invasive fungal infection prophylaxis itraconazole AML acute myeoloid leukemia IFI invasive fungal infection prophylaxis itraconazole
Conditions
Interventions
Itraconazole 300 mg per oral with meal twice daily for the first 3 days then 200 mg per oral with meal twice daily,Placebo capsule 3 capsules per oral with meal twice daily with meal for th first 3 da
Experimental Drug,Placebo Comparator No treatment
Itraconazole capsule,placebo
Sponsors
siriraj oncology foundation
Thai society of hematology
Eligibility
Sex/Gender
All
Age
15 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| invasive fungal infection incidence day 42 of induction chemotherapy descriptive analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| mortality rate day 42 of induction chemotherapy descriptive analysis | — |
Contacts
Public ContactPloyploen Phikulsod
Faculty of medicine Siriraj hospital
Outcome results
None listed