Early Stoppage Versus Continuation of Antimicrobial Therapy in Low Risk Pediatric Cancer Patients With Febrile Neutropenia, Before Recovery of Counts: -DALFEN Study
NCT ID: NCT03003273
Last Updated: 2019-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
142 participants
INTERVENTIONAL
2017-01-31
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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
* Already enrolled once, in previous episode
* On antibiotics prophylaxis
* Retroviral positive patients
* Patient undergone stem cell transplant
3 Years
18 Years
ALL
No
Sponsors
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All India Institute of Medical Sciences
OTHER
Responsible Party
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AKASH KUMAR
Senior Resident (DM course)
Principal Investigators
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Sameer Bakhshi, Professor
Role: STUDY_DIRECTOR
Department of Medical Oncology, 2nd Floor, B.R.A.I.R.C.H, All India Institute of Medical Sciences, New Delhi, India
Locations
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Department of Medical Oncology, AIIMS
New Delhi, , India
Countries
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Other Identifiers
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IECPG-164
Identifier Type: -
Identifier Source: org_study_id
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