Invasive Pulmonary Aspergillosis (IPA) between patients receiving voriconazole and those not receiving it, within 60 days after patients with Acute Myeloid Leukemia (AML) receive chemotherapy. Invasive pulmonary aspergillosis
Conditions
Interventions
Voriconazole 400 mg/day for weight more than 40 kg 200 mg/day for weight less than 40 kg. until recovery from neutropenia (ANC more than 1,500) or at least 3 weeks.,No
Active Comparator Drug,No Intervention No treatment
Voriconazole group,Standard treatment group
Sponsors
Siam Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Diagnosed with AML and receiving Induction or Consolidation chemotherapy within the first 24 hours 2. Aged 18 years and older 3. Chest X-ray showing no suspicious lung lesions for fungal infection which were interpreted by a radiologist or specialist.
Exclusion criteria
Exclusion criteria: 1.Prior diagnosis of IPA within the last year 2. Received antifungal therapy within 7 days prior to chemotherapy, 3. Abnormal liver function (AST/ALT > 3x upper limit; Total Bilirubin > 2 mg/dL), 4. History of allergy to Azole antifungals, 5. Taking medications that have interaction with voriconazole.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of Invasive Pulmonary Aspergillosis 60 days after Patient reported outcome using record form | — |
Secondary
| Measure | Time frame |
|---|---|
| incidence of febrile neutropenia and study the incidence of other hospital-acquired infections 60 days Patient reported outcome using record form | — |
Countries
Thailand
Contacts
Public ContactKridsada Wiroonhatum
Mahidol University
Outcome results
None listed