Health Condition 1: C910- Acute lymphoblastic leukemia [ALL] Health Condition 2: C920- Acute myeloblastic leukemia
Conditions
Interventions
Intervention1: Oral fluconazole plus inhalational amphotericin B: 1. Oral fluconazole, 12 mg/kg/day, once a day
2. Inhalational Liposomal Amphotericin B, 25 mg per dose, once a day for 2 days per week
Sponsors
Naga Geetha Rani Mangam
Eligibility
Inclusion criteria
Inclusion criteria: 1. Newly diagnosed children with high risk ALL, intermediate risk ALL, AML or relapsed ALL 2. Normal renal function 3. Normal liver function
Exclusion criteria
Exclusion criteria: 1. Patients with a diagnosis of APML, Down syndrome associated leukemia or JMML 2. Documented history of invasive fungal infection 3 months prior to enrollment 3. Patients already receiving treatment for invasive fungal infection 4. Hypersensitivity reaction documented for L amphotericin B or fluconazole or voriconazole
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of invasive fungal infections (proven, probable or possible)Timepoint: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to onset of fungal infection from chemotherapy initiation to the first episode of fungal infectionTimepoint: 3 months;Incidence, nature, and severity of adverse events (AEs) during the studyTimepoint: 3 months;Sensitivity, specificity, and predictive value of serum galactomannan for early detection of invasive fungal infections.Timepoint: 3 months;Association of fungal infections with voriconazole trough levelsTimepoint: 3 months | — |
Countries
India
Contacts
Public ContactDebasish Sahoo
AIIMS, Bhubaneswar
Outcome results
None listed