Early Discontinuation versus Continuation of Antimicrobial Therapy in Low Risk Pediatric Cancer Patients with Febrile Ne
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ORIGINAL ARTICLE
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) Akash Kumar 1 & Bivas Biswas 1 & Anita Chopra 2 & Arti Kapil 3 & Sreenivas Vishnubhatla 4 & Sameer Bakhshi 1 Received: 26 December 2019 / Accepted: 1 June 2020 # Dr. K C Chaudhuri Foundation 2020
Abstract Objective To 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. Methods In 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. Results From 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. Conclusions Antimicrobial therapy in low risk afebrile neutropenic patients can be stopped early. This approach can lead to significant cost and resource benefits. Keywords Febrile neutropenia . Neutropenia . Children . Empirical antibiotics . Low risk . Withdrawal
Introduction Febrile neutropenia is a common complication arising in pediatric cancer patients during the course of chemotherapy. For long, given a likely possibility of an adverse outcome, the approach in such cases has been to start empirical antimicrobials at the earliest. The choice of agents is modified as further ClinicalTrials.gov, number NCT03003273 * Sameer Bakhshi [email protected] 1
Department of Medical Oncology, Dr. BRA IRCH, AIIMS, New Delhi, India
2
Department of Lab Oncology, Dr. BRA IRCH, AIIMS, New Delhi, India
3
Department of Microbiology, AIIMS, New Delhi, India
4
Department of Biostatistics, AIIMS, New Delhi, India
investigations reveal any specific organism and/or depending on the clinical assessment of the patient. In a large number of cases, no definite focus of infection can be identified. The optimal management approaches such as total duration of antibiotics, whether to administer antibiotics in inpatient or outpatient setting, and if antibiotics can be stopped prior to recovery of neutrophils are still debatable. Various studies have been done in pediatric patients with
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