Health Condition 1: null- High Risk Febrile Neutropenia pediatric cancer patients
Conditions
Interventions
Intervention1: Arm A-ECIL(Expert Group of the 4th European Conference on Infections in Leukemia) approach
Arm-B (Infectious Diseases Society of America) approach: Arm-A: , empiric intravenous antibiot
Sponsors
Dr Brijesh Arora
Eligibility
Inclusion criteria
Inclusion criteria: (1) Subjects with ages 2 to 24 years (2) Receiving chemotherapy for a) newly diagnosed, relapsed or secondary AML; b) newly diagnosed ALL in induction or delayed intensification c) relapsed ALL in induction, consolidation, or intensification; d) advanced stage Burkitt lymphoma in induction or consolidation of LMB protocol. (3) Febrile neutropenia defined as fever (temperature � 38�C on two occasions within a 12 hour period or � 38.3�C once) during neutropenia (absolute neutrophil count (4) At days 3-5, (A) meet criteria for antibiotic cessation consisting of: a) absence of fever (38.0° C) for at least 24 hours; (b) absence of a clinically or microbiologically documented infection for which antibiotic treatment after day 5 of febrile neutropenia would be required; and (c) absence of major co-morbidity such as severe grade 3 or greater (via CTCAE version 4.0) severe mucositis or abdominal pain, vomiting, hypotension, respiratory distress, or neurological signs or symptoms and (B) remain neutropenic with an absolute neutrophil count
Exclusion criteria
Exclusion criteria: (1) Previous enrollment on the trial (2) Renal insufficiency on day 1 of febrile neutropenia defined via a calculated creatinine clearance < 70mL/min/1.73m2 or a higher than normal serum creatinine based on age/gender.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the reduction in antibiotic use by comparing the duration of intravenous antibiotics in 2 armsTimepoint: During inpatient admission for incidences of febrile neutropenia | — |
Secondary
| Measure | Time frame |
|---|---|
| To describe the differences between the two groups of patients in the following outcome measures of interest: 1. Proportion with successful episodes 2. Proportion with morbidity 3. Proportion with complications 4. Cost of care 5. Febrile neutropenia related mortality 6. Proportion with nephrotoxicity 7. Proportion with a delay in chemotherapy secondary to infection or neutropeniaTimepoint: During inpatient admission for incidences of febrile neutropenia | — |
Countries
India
Contacts
Public ContactDr Brijesh Arora
Tata Memorial Hospital
Outcome results
None listed