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

Primary Purpose

Neutropenia, Febrile, Pediatric Cancer

Status
Terminated
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
stoppage of antibiotics
amoxycillin/clavulanic acid
levofloxacin
Sponsored by
All India Institute of Medical Sciences, New Delhi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neutropenia, Febrile

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Medical Oncology, AIIMS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

arm (A) - stoppage of antibiotics

arm (B) - oral antibiotics till ANC ≥ 500

Arm Description

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.

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.

Outcomes

Primary Outcome 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

Secondary Outcome Measures

Rate of re-admission

Full Information

First Posted
December 13, 2016
Last Updated
January 30, 2019
Sponsor
All India Institute of Medical Sciences, New Delhi
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1. Study Identification

Unique Protocol Identification Number
NCT03003273
Brief Title
Early Stoppage Versus Continuation of Antimicrobial Therapy in Low Risk Pediatric Cancer Patients With Febrile Neutropenia, Before Recovery of Counts: -DALFEN Study
Acronym
DALFEN
Official Title
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
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
poor accrual
Study Start Date
January 2017 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
All India Institute of Medical Sciences, New Delhi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neutropenia, Febrile, Pediatric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
142 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
arm (A) - stoppage of antibiotics
Arm Type
Experimental
Arm Description
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.
Arm Title
arm (B) - oral antibiotics till ANC ≥ 500
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
stoppage of antibiotics
Intervention Description
antibiotics will be stopped in arm - A on randomization, once child is afebrile for at least 24 hours and fulfills the inclusion criteria.
Intervention Type
Other
Intervention Name(s)
amoxycillin/clavulanic acid
Intervention Description
In arm - B, once the child is randomized, oral antibiotics will be started (Amoxicillin/ Clavulanic acid + Levofloxacin)
Intervention Type
Other
Intervention Name(s)
levofloxacin
Intervention Description
In arm - B, once the child is randomized, oral antibiotics will be started (Amoxicillin/ Clavulanic acid + Levofloxacin)
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Rate of re-admission
Time Frame
till ANC ≥ 500 or reappearance of fever during the period ≤10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameer Bakhshi, Professor
Organizational Affiliation
Department of Medical Oncology, 2nd Floor, B.R.A.I.R.C.H, All India Institute of Medical Sciences, New Delhi, India
Official's Role
Study Director
Facility Information:
Facility Name
Department of Medical Oncology, AIIMS
City
New Delhi
ZIP/Postal Code
110029
Country
India

12. IPD Sharing Statement

Learn more about this trial

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

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