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

Sponsor

All India Institute of Medical Sciences, New Delhi (Other)

Overall Status

Terminated

CT.gov ID

NCT03003273

Collaborator

(none)

142

Enrollment

Location

Arms

Actual Duration (Months)

6.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Neutropenia, Febrile Pediatric Cancer	Other: stoppage of antibiotics Other: amoxycillin/clavulanic acid Other: levofloxacin	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

142 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Dec 1, 2018

Actual Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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.	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.
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.	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)

Arm

Intervention/Treatment

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.

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.

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.

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)

Outcome Measures

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

Secondary Outcome Measures

Rate of re-admission [till ANC ≥ 500 or reappearance of fever during the period ≤10 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Medical Oncology, AIIMS	New Delhi		India	110029

Sponsors and Collaborators

All India Institute of Medical Sciences, New Delhi

Investigators

Study Director: 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