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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 (DALFEN)

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ClinicalTrials.gov Identifier: NCT03003273
Recruitment Status : Recruiting
First Posted : December 28, 2016
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
AKASH KUMAR, 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.

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

Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Fever

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)




Primary Outcome Measures :
  1. 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 [ Time Frame: till ANC ≥ 500 or reappearance of fever during the period ≤ 10 days ]

Secondary Outcome Measures :
  1. Rate of re-admission [ Time Frame: till ANC ≥ 500 or reappearance of fever during the period ≤10 days ]


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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03003273


Contacts
Contact: SAMEER BAKHSHI, Professor 011-29575237 sambakh@hotmail.com
Contact: Akash Kumar, MD 919910850134

Locations
India
Department of Medical Oncology, AIIMS Recruiting
New Delhi, India, 110029
Contact: Sameer Bakhshi, MD    011-29575237    sambakh@hotmail.com   
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

Responsible Party: AKASH KUMAR, Senior Resident (DM course), All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT03003273     History of Changes
Other Study ID Numbers: IECPG-164
First Posted: December 28, 2016    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Fever
Febrile Neutropenia
Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Body Temperature Changes
Signs and Symptoms
Anti-Bacterial Agents
Amoxicillin
Levofloxacin
Ofloxacin
Clavulanic Acids
Clavulanic Acid
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Anti-Infective Agents, Urinary
Renal Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
beta-Lactamase Inhibitors