Health Condition 1: B998- Other infectious disease
Conditions
Interventions
Intervention1: Tab Posaconazole: Group 1 (AML) - Tablet Posaconazole will be given at the dose of 300 mg twice daily on day1 followed by 300 mg once daily. Will be given till recovery of blood counts
Sponsors
Christian Medical College
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients diagnosed to have acute myeloid leukemia receiving intensive chemotherapy [7+3 induction, Salvage chemotherapy with FLAG/FLAG-Ida/5+5 chemotherapy] â?? Group 1 2.Patients who have developed acute GVHD after allogeneic HSCT and are initiated on corticosteroids at 1-2 mg/Kg/day â?? Group 2 3.Adults > 15 years of age
Exclusion criteria
Exclusion criteria: 1. Patients with AML receiving azacytidine/decitabine based chemotherapy 2. Patients following HSCT who are already on mold prophylaxis or amphotericin 3. Patients present with invasive fungal infection at diagnosis 4. Patients with > grade 3 hepatic dysfunction ie Total Billirubin > 3 mg% and/or SGOT/SGPT > 200 IU/L 5.Patients where the expected life expectancy is less than 1 week
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the rate of invasive fungal infection in patients receiving oral tablet Posaconazole prophylaxis for HSCT or AMLTimepoint: 30days | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢To determine if Tablet Posaconazole achieves therapeutic levels in a higher number of patients undergoing HSCT or chemotherapy for AML [plasma levels of 0.7 mg/L] on Day 2, 4, 10 and 14 â?¢To determine the rate of requirement of change in the dose of Posaconazole â?¢To determine the number of adverse events or discontinuation noted during 30 days of initiation of Posaconazole prophylaxis â?¢To determine the correlation between Posaconazole trough concentrations and incidence of IFI.Timepoint: 30 days | — |
Countries
India
Contacts
Public ContactBiju George Christian Medical College
Christian Medical College
Outcome results
None listed