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

NCT03003273 — Phase 3, Terminated, 142 participants, All India Institute of Medical Sciences

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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

Registry	NCT03003273, acronym DALFEN
Status	Terminated - poor accrual
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	142 (Estimated)
Sponsor	All India Institute of Medical Sciences (Other)
Conditions	Neutropenia, Febrile, Pediatric Cancer
Interventions	stoppage of antibiotics, amoxycillin/clavulanic acid, levofloxacin (Other)
Dates	start 2017-01-01, primary completion 2018-12-01, completion 2018-12-01, first posted 2016-12-28, last updated 2019-02-01
Locations	1 site in India

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
arm (A) - stoppage of antibiotics	Experimental	Other: 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.
arm (B) - oral antibiotics till ANC ≥ 500	Active comparator	Other: amoxycillin/clavulanic acid; Other: levofloxacin	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.

stoppage of antibiotics (Other): 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 (Other): In arm - B, once the child is randomized, oral antibiotics will be started (Amoxicillin/ Clavulanic acid + Levofloxacin)
levofloxacin (Other): In arm - B, once the child is randomized, oral antibiotics will be started (Amoxicillin/ Clavulanic acid + Levofloxacin)

+Outcome measures

Primary outcomes

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 outcomes

Rate of re-admission [till ANC ≥ 500 or reappearance of fever during the period ≤10 days]

+Eligibility

Sex: All, ages: 3 Years to 18 Years

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

+Locations (1)

Facility	City	Country	Status
Department of Medical Oncology, AIIMS	New Delhi	India

+Investigators

Sameer Bakhshi, Professor, Study director, Department of Medical Oncology, 2nd Floor, B.R.A.I.R.C.H, All India Institute of Medical Sciences, New Delhi, India

My Notes

Public

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