<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03003273</url>
  </required_header>
  <id_info>
    <org_study_id>IECPG-164</org_study_id>
    <nct_id>NCT03003273</nct_id>
  </id_info>
  <brief_title>Early Stoppage Versus Continuation of Antimicrobial Therapy in Low Risk Pediatric Cancer Patients With Febrile Neutropenia, Before Recovery of Counts: -DALFEN Study</brief_title>
  <acronym>DALFEN</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>All India Institute of Medical Sciences, New Delhi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>All India Institute of Medical Sciences, New Delhi</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pediatric patients with febrile neutropenia coming to Department of Medical Oncology with low&#xD;
      risk features (culture awaited), will be started on intravenous antibiotics (Inj&#xD;
      Cefoperazone+ Sulbactam ± Amikacin) on outpatient basis. Those patients will be reassessed&#xD;
      for randomization once they fulfill all inclusion criteria and get afebrile for at least 24&#xD;
      hours. Antibiotics will be stopped in Arm-A and oral antibiotics, in place of intravenous&#xD;
      antibiotics, will be started in Arm-B. The patients will be followed-up till ANC≥ 500, or&#xD;
      reappearance of fever within follow-up of ≤ 10 days.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    poor accrual&#xD;
  </why_stopped>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">December 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>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</measure>
    <time_frame>till ANC ≥ 500 or reappearance of fever during the period ≤ 10 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of re-admission</measure>
    <time_frame>till ANC ≥ 500 or reappearance of fever during the period ≤10 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">142</enrollment>
  <condition>Neutropenia, Febrile</condition>
  <condition>Pediatric Cancer</condition>
  <arm_group>
    <arm_group_label>arm (A) - stoppage of antibiotics</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>arm (B) - oral antibiotics till ANC ≥ 500</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>stoppage of antibiotics</intervention_name>
    <description>antibiotics will be stopped in arm - A on randomization, once child is afebrile for at least 24 hours and fulfills the inclusion criteria.</description>
    <arm_group_label>arm (A) - stoppage of antibiotics</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>amoxycillin/clavulanic acid</intervention_name>
    <description>In arm - B, once the child is randomized, oral antibiotics will be started (Amoxicillin/ Clavulanic acid + Levofloxacin)</description>
    <arm_group_label>arm (B) - oral antibiotics till ANC ≥ 500</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>levofloxacin</intervention_name>
    <description>In arm - B, once the child is randomized, oral antibiotics will be started (Amoxicillin/ Clavulanic acid + Levofloxacin)</description>
    <arm_group_label>arm (B) - oral antibiotics till ANC ≥ 500</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All pediatric febrile neutropenia patients treated on outpatient basis&#xD;
&#xD;
          -  Age 3 years - 18 years&#xD;
&#xD;
          -  Fulfilling low risk criteria ( Hematological malignancies in remission, No&#xD;
             identifiable focus of infection, No Pneumonia/ mucositis / GI sepsis /&#xD;
             Nausea-vomiting/ neurologic-mental status changes/ Central Venous Catheter (CVC)&#xD;
             related infection, Anticipated Absolute Neutrophil Count (ANC) recovery ≤ 10 days, No&#xD;
             organ dysfunction, Hemodynamically stable, Culture negative )&#xD;
&#xD;
          -  Afebrile for at least 24 hours, on intra-venous antibiotics&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bone marrow involvement in solid tumor&#xD;
&#xD;
          -  Already enrolled once, in previous episode&#xD;
&#xD;
          -  On antibiotics prophylaxis&#xD;
&#xD;
          -  Retroviral positive patients&#xD;
&#xD;
          -  Patient undergone stem cell transplant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sameer Bakhshi, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Department of Medical Oncology, 2nd Floor, B.R.A.I.R.C.H, All India Institute of Medical Sciences, New Delhi, India</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Medical Oncology, AIIMS</name>
      <address>
        <city>New Delhi</city>
        <zip>110029</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>All India Institute of Medical Sciences, New Delhi</investigator_affiliation>
    <investigator_full_name>AKASH KUMAR</investigator_full_name>
    <investigator_title>Senior Resident (DM course)</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neutropenia</mesh_term>
    <mesh_term>Febrile Neutropenia</mesh_term>
    <mesh_term>Hyperthermia</mesh_term>
    <mesh_term>Fever</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Bacterial Agents</mesh_term>
    <mesh_term>Amoxicillin</mesh_term>
    <mesh_term>Levofloxacin</mesh_term>
    <mesh_term>Clavulanic Acids</mesh_term>
    <mesh_term>Clavulanic Acid</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03003273
org study id: IECPG-164
nct id: NCT03003273
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 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
measure: Rate of re-admission
time frame: till ANC ≥ 500 or reappearance of fever during the period ≤10 days
arm group label: arm (A) - stoppage of antibiotics
arm group type: Experimental
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.
arm group label: arm (B) - oral antibiotics till ANC ≥ 500
arm group type: Active Comparator
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.
intervention type: Other
intervention name: stoppage of antibiotics
description: antibiotics will be stopped in arm - A on randomization, once child is afebrile for at least 24 hours and fulfills the inclusion criteria.
arm group label: arm (A) - stoppage of antibiotics
intervention type: Other
intervention name: amoxycillin/clavulanic acid
description: In arm - B, once the child is randomized, oral antibiotics will be started (Amoxicillin/ Clavulanic acid + Levofloxacin)
arm group label: arm (B) - oral antibiotics till ANC ≥ 500
intervention type: Other
intervention name: levofloxacin
description: In arm - B, once the child is randomized, oral antibiotics will be started (Amoxicillin/ Clavulanic acid + Levofloxacin)
arm group label: arm (B) - oral antibiotics till ANC ≥ 500
criteria: 
gender: All
minimum age: 3 Years
maximum age: 18 Years
healthy volunteers: No
last name: Sameer Bakhshi, Professor
role: Study Director
affiliation: Department of Medical Oncology, 2nd Floor, B.R.A.I.R.C.H, All India Institute of Medical Sciences, New Delhi, India
facility: 
country: India
responsible party type: Principal Investigator
investigator affiliation: All India Institute of Medical Sciences, New Delhi
investigator full name: AKASH KUMAR
investigator title: Senior Resident (DM course)
mesh term: Neutropenia
mesh term: Febrile Neutropenia
mesh term: Hyperthermia
mesh term: Fever
mesh term: Anti-Bacterial Agents
mesh term: Amoxicillin
mesh term: Levofloxacin
mesh term: Clavulanic Acids
mesh term: Clavulanic Acid