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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

NCT03003273 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2019-02-01

No results posted yet for this study

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.

Conditions

  • Neutropenia, Febrile
  • Pediatric Cancer

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)

Sponsors & Collaborators

  • All India Institute of Medical Sciences

    lead OTHER

Principal Investigators

  • 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 Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03003273 on ClinicalTrials.gov