Tab Posaconazole study in patients with cancers
Not Applicable
- Conditions
- Health Condition 1: B998- Other infectious disease
- Registration Number
- CTRI/2021/03/032019
- Lead Sponsor
- Christian Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the rate of invasive fungal infection in patients receiving oral <br/ ><br>tablet Posaconazole prophylaxis for HSCT or AMLTimepoint: 30days
- Secondary Outcome Measures
Name Time Method 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 <br/ ><br>â?¢To determine the rate of requirement of change in the dose of Posaconazole <br/ ><br>â?¢To determine the number of adverse events or discontinuation noted during 30 days of initiation of Posaconazole prophylaxis <br/ ><br>â?¢To determine the correlation between Posaconazole trough concentrations and incidence of IFI.Timepoint: 30 days