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

All India Institute Of Medical Science (AIIMS)

Status and phase: Terminated; Phase 3

Conditions: Neutropenia, Febrile; Pediatric Cancer

Treatments: Other: levofloxacin; Other: amoxycillin/clavulanic acid; Other: stoppage of antibiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT03003273

IECPG-164

Details and patient eligibility

About

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.

Enrollment: 142 estimated patients

Sex: All

Ages: 3 to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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142 participants in 2 patient groups

arm (A) - stoppage of antibiotics

Experimental group

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.

Treatment:

Other: stoppage of antibiotics

arm (B) - oral antibiotics till ANC ≥ 500

Active Comparator group

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.

Treatment:

Other: amoxycillin/clavulanic acid

Other: levofloxacin