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

Phase 3

Terminated

• Conditions: Pediatric Cancer; Neutropenia, Febrile
• Interventions: Other: amoxycillin/clavulanic acid; Other: stoppage of antibiotics; Other: levofloxacin

• Registration Number: NCT03003273
• Lead Sponsor: All India Institute of Medical Sciences, New Delhi

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-13
• Study First Submitted QC: 2016-12-27
• Study First Posted: 2016-12-28
• Study Start: 2017-01
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-30
• Last Update Posted: 2019-02-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 142

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
arm (B) - oral antibiotics till ANC ≥ 500	levofloxacin	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.
arm (B) - oral antibiotics till ANC ≥ 500	amoxycillin/clavulanic acid	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.
arm (A) - stoppage of antibiotics	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Rate of re-admission	till ANC ≥ 500 or reappearance of fever during the period ≤10 days

Trial Locations

Locations (1)

Department of Medical Oncology, AIIMS; 🇮🇳 New Delhi, India