NCT03003273

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 28, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 1, 2019

Status Verified

January 1, 2019

Enrollment Period

1.9 years

First QC Date

December 13, 2016

Last Update Submit

January 30, 2019

Conditions

Neutropenia, FebrilePediatric Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Rate of re-admission

    till ANC ≥ 500 or reappearance of fever during the period ≤10 days

Study Arms (2)

arm (A) - stoppage of antibiotics

EXPERIMENTAL

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.

Other: stoppage of antibiotics

arm (B) - oral antibiotics till ANC ≥ 500

ACTIVE COMPARATOR

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.

Other: amoxycillin/clavulanic acidOther: levofloxacin

Interventions

stoppage of antibioticsOTHER

antibiotics will be stopped in arm - A on randomization, once child is afebrile for at least 24 hours and fulfills the inclusion criteria.

arm (A) - stoppage of antibiotics
amoxycillin/clavulanic acidOTHER

In arm - B, once the child is randomized, oral antibiotics will be started (Amoxicillin/ Clavulanic acid + Levofloxacin)

arm (B) - oral antibiotics till ANC ≥ 500
levofloxacinOTHER

In arm - B, once the child is randomized, oral antibiotics will be started (Amoxicillin/ Clavulanic acid + Levofloxacin)

arm (B) - oral antibiotics till ANC ≥ 500

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Bone marrow involvement in solid tumor
  • Already enrolled once, in previous episode
  • On antibiotics prophylaxis
  • Retroviral positive patients
  • Patient undergone stem cell transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medical Oncology, AIIMS

New Delhi, 110029, India

Location

MeSH Terms

Conditions

Febrile NeutropeniaNeoplasms

Interventions

Amoxicillin-Potassium Clavulanate CombinationLevofloxacin

Condition Hierarchy (Ancestors)

NeutropeniaAgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte Disorders

Intervention Hierarchy (Ancestors)

Clavulanic AcidClavulanic Acidsbeta-LactamsLactamsAmidesOrganic ChemicalsAmoxicillinAmpicillinPenicillin GPenicillinsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical PreparationsOfloxacinFluoroquinolones4-QuinolonesQuinolonesQuinolines

Study Officials

  • Sameer Bakhshi, Professor

    Department of Medical Oncology, 2nd Floor, B.R.A.I.R.C.H, All India Institute of Medical Sciences, New Delhi, India

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Resident (DM course)

Study Record Dates

First Submitted

December 13, 2016

First Posted

December 28, 2016

Study Start

January 1, 2017

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

February 1, 2019

Record last verified: 2019-01

Locations

IN(1)