A clinical trial to compare the effectiveness of oral versus intravenous antibiotics for in-patient management of low-risk febrile neutropenia in pediatric acute lymphoblastic leukemia
Not Applicable
- Conditions
- Health Condition 1: null- Low-risk febrile neutropenia in pediatric acute lymphoblastic leukemia patients
- Registration Number
- CTRI/2017/12/010796
- Lead Sponsor
- Institutional intramural research grant
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Clinically stable children aged <12 years with Acute lymphoblastic leukemia diagnosed with low-risk febrile neutropenia (LRFN)
Exclusion Criteria
1.Prior antibiotic treatment within 7 days of occurrence of current episode of febrile neutropenia
2. Acute lymphoblastic leukemia patients who have undergone bone marrow transplantation or stem cell transplantation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment success â?? Resolution of the febrile episode (afebrile for more than 24 hours) and ANC count above the baseline value while receiving the treatment in the allocated groupTimepoint: 0-7 days
- Secondary Outcome Measures
Name Time Method Fever clearance timeTimepoint: 0-7 days;hsCRP level at the onset of febrile neutropeniaTimepoint: DAY 1;Procalcitonin Clearance (at 48 hours)Timepoint: DAY 1 and DAY 3;Re-admission ratesTimepoint: within 7 days of resolution of febrile neutropenia;Time for the recovery of counts (absolute neutrophil count) - time required for ANC to become 500/µLTimepoint: 0-7 days