Neutropenia, Febrile, Pediatric Cancer
Conditions
Brief summary
Pediatric patients with febrile neutropenia coming to Department of Medical Oncology with low risk features (culture awaited), will be started on intravenous antibiotics (Inj Cefoperazone+ Sulbactam ± Amikacin) on outpatient basis. Those patients will be reassessed for randomization once they fulfill all inclusion criteria and get afebrile for at least 24 hours. Antibiotics will be stopped in Arm-A and oral antibiotics, in place of intravenous antibiotics, will be started in Arm-B. The patients will be followed-up till ANC≥ 500, or reappearance of fever within follow-up of ≤ 10 days.
Interventions
OTHERstoppage of antibiotics
antibiotics will be stopped in arm - A on randomization, once child is afebrile for at least 24 hours and fulfills the inclusion criteria.
In arm - B, once the child is randomized, oral antibiotics will be started (Amoxicillin/ Clavulanic acid + Levofloxacin)
OTHERlevofloxacin
In arm - B, once the child is randomized, oral antibiotics will be started (Amoxicillin/ Clavulanic acid + Levofloxacin)
Sponsors
All India Institute of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* All pediatric febrile neutropenia patients treated on outpatient basis * Age 3 years - 18 years * Fulfilling low risk criteria ( Hematological malignancies in remission, No identifiable focus of infection, No Pneumonia/ mucositis / GI sepsis / Nausea-vomiting/ neurologic-mental status changes/ Central Venous Catheter (CVC) related infection, Anticipated Absolute Neutrophil Count (ANC) recovery ≤ 10 days, No organ dysfunction, Hemodynamically stable, Culture negative ) * Afebrile for at least 24 hours, on intra-venous antibiotics
Exclusion criteria
* Bone marrow involvement in solid tumor * Already enrolled once, in previous episode * On antibiotics prophylaxis * Retroviral positive patients * Patient undergone stem cell transplant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment is considered to be successful if the following is attained without changing the regimen - Patient remains afebrile till recovery of ANC ≥500 •Measure of effect: Proportion of patients afebrile in each arm | till ANC ≥ 500 or reappearance of fever during the period ≤ 10 days |
Secondary
| Measure | Time frame |
|---|---|
| Rate of re-admission | till ANC ≥ 500 or reappearance of fever during the period ≤10 days |
Countries
India
Outcome results
None listed