Trial reportIndian journal of pediatrics2021
Early Discontinuation versus Continuation of Antimicrobial Therapy in Low Risk Pediatric Cancer Patients with Febrile Neutropenia, Before Recovery of Counts: A Randomized Controlled Trial (DALFEN Study).
Trial report in Indian journal of pediatrics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 25 citations in OpenAlex.
- Early discontinuation vs. continuation of empirical antibiotics in patients with cancer and febrile neutropenia: a systematic review and meta-analysis of randomized controlled trials.Frontiers in microbiology · 2026Pooled it
- Guideline for the Management of Fever and Neutropenia in Pediatric Patients With Cancer and Hematopoietic Cell Transplantation Recipients: 2023 Update.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023Guideline
- Step-down management of fever and neutropenia in low-risk pediatric and adolescent-young adult oncology patients is safe and effective: a single center experience.Pediatric hematology and oncology · 2026Article
- Early Discontinuation of Empiric Antibiotic Therapy in Children with Cancer and Febrile Neutropenia: A Narrative Review.Medicina (Kaunas, Lithuania) · 2026Review
- Early stoppage of empirical antibiotic therapy in paediatric acute leukaemia with high-risk febrile neutropenia: a randomized, open-label, phase 3, non-inferiority trial.EClinicalMedicine · 2025Article
- Article
- Fever and neutropenia in pediatric oncology and stem cell transplant patients: an editorial commentary on updated international clinical practice guidelines.Translational pediatrics · 2023Article
- Review
- Shorter Duration of Antibiotics in Low-Risk Febrile Neutropenia in Children with Malignancy.Indian journal of pediatrics · 2021Article
Corrections and comments
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Authors and funding
6 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo determine if early discontinuation of antimicrobials in pediatric patients with low risk febrile neutropenia is as effective as continuing therapy before recovery of counts, in an outpatient setting.
methodsIn an open label, non-inferiority, randomized controlled phase 3 trial at a tertiary cancer center, patients aged 3-18 y, with low risk febrile neutropenia were started on empirical intra-venous antibiotics in an outpatient setting. Randomization was done when the patients became afebrile for at least 24 h; standard arm consisted of oral antibiotics, while antibiotics were stopped in the experimental arm. Enrolled patients were followed for re-appearance of fever and rate of re-admission, until ANC ≥ 500. A pilot feasibility randomized study with similar design preceded this trial.
resultsFrom Jan 2017-Dec 2018, 75 patients were randomized: 38 to stoppage arm while 37 patients received oral antibiotics. Baseline characteristics were equally matched. Success rates were 94.6% in the continuation arm vs. 94.7% in the stoppage arm; absolute risk difference was 0.1% (95% CI: -10.0% to +10.3%), thus suggesting that the experimental arm is non-inferior to the standard arm. There was no re-admission on failure in any arm.
conclusionsAntimicrobial therapy in low risk afebrile neutropenic patients can be stopped early. This approach can lead to significant cost and resource benefits.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.