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

Pediatric Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03003273
• Other study ID #: IECPG-164
• Status: Terminated
• Phase: Phase 3
• Start date: January 2017
• Est. completion date: December 2018

Study information

• Verified date: January 2019
• Source: All India Institute of Medical Sciences, New Delhi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 142
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Febrile Neutropenia
• Fever
• Neutropenia
• Neutropenia, Febrile
• Pediatric Cancer

Intervention

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.
• amoxycillin/clavulanic acid
In arm - B, once the child is randomized, oral antibiotics will be started (Amoxicillin/ Clavulanic acid + Levofloxacin)
• levofloxacin
In arm - B, once the child is randomized, oral antibiotics will be started (Amoxicillin/ Clavulanic acid + Levofloxacin)

Locations

Country	Name	City	State
India	Department of Medical Oncology, AIIMS	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, New Delhi

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of re-admission		till ANC = 500 or reappearance of fever during the period =10 days