Akash Kumar1, Bivas Biswas1, Anita Chopra2, Arti Kapil3, Sreenivas Vishnubhatla4, Sameer Bakhshi5. 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. 5. Department of Medical Oncology, Dr. BRA IRCH, AIIMS, New Delhi, India. sambakh@hotmail.com.
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 receivedoral 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 riskafebrile neutropenic patients can be stopped early. This approach can lead to significant cost and resource benefits.
RCT Entities:
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 neutropenicpatients can be stopped early. This approach can lead to significant cost and resource benefits.