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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

Efficacy of oral versus intravenous antibiotics for in-patient management of low-risk febrile neutropenia in pediatric acute lymphoblastic leukemia â?? an open label randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/12/010796
Enrollment
80
Registered
2017-12-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Low-risk febrile neutropenia in pediatric acute lymphoblastic leukemia patients

Interventions

Intervention1: ORAL ANTIBIOTICS: Oral Amoxicillin-Clavulanate (amoxicillin base 40 mg/kg/day in 3 divided doses
maximal dose of amoxicillin base 500 mg/dose) plus Ciprofloxacin (30 mg/kg/day in 3 divided doses
maximal dose 500 mg/dose) Control Intervention1: INTRAVENOUS ANTIBIOTICS: Intravenous Ceftriaxone (75 mg/kg/day in 2 divided doses
maximal dose 1000 mg/dose) and Amikacin (15 mg/kg/day in single daily dose
maximal dose 1500 mg/day)

Sponsors

Institutional intramural research grant
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Clinically stable children aged <12 years with Acute lymphoblastic leukemia diagnosed with low-risk febrile neutropenia (LRFN)

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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—

Countries

India

Contacts

Public ContactMadhuchandan M

University of Delhi

sunilgomber@hotmail.com9810654564

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026