Early Stoppage Versus Continuation of Antimicrobial Therapy in Low Risk Pediatric Cancer Patients With Febrile Neutropenia, Before Recovery of Counts: -DALFEN Study

Overview

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.

Full Title of Study: “Early Stoppage Versus Continuation of Antimicrobial Therapy in Low Risk Pediatric Cancer Patients With Febrile Neutropenia, Before Recovery of Counts: a Randomized Controlled Study -DALFEN Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2018

Interventions

  • Other: stoppage 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.
  • Other: amoxycillin/clavulanic acid
    • In arm – B, once the child is randomized, oral antibiotics will be started (Amoxicillin/ Clavulanic acid + Levofloxacin)
  • Other: levofloxacin
    • In arm – B, once the child is randomized, oral antibiotics will be started (Amoxicillin/ Clavulanic acid + Levofloxacin)

Arms, Groups and Cohorts

  • Experimental: arm (A) – stoppage of antibiotics
    • 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.
  • Active Comparator: arm (B) – oral antibiotics till ANC ≥ 500
    • patients will be reassessed for randomization once they fulfill all inclusion criteria and get afebrile for at least 24 hours. oral antibiotics, in place of intravenous antibiotics, will be started in Arm-B.

Clinical Trial Outcome Measures

Primary Measures

  • 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
    • Time Frame: till ANC ≥ 500 or reappearance of fever during the period ≤ 10 days

Secondary Measures

  • Rate of re-admission
    • Time Frame: till ANC ≥ 500 or reappearance of fever during the period ≤10 days

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 3 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • All India Institute of Medical Sciences, New Delhi
  • Provider of Information About this Clinical Study
    • Principal Investigator: AKASH KUMAR, Senior Resident (DM course) – All India Institute of Medical Sciences, New Delhi
  • Overall Official(s)
    • Sameer Bakhshi, Professor, Study Director, Department of Medical Oncology, 2nd Floor, B.R.A.I.R.C.H, All India Institute of Medical Sciences, New Delhi, India

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