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BackgroundIn November 2020, the US Food and Drug Administration (FDA) provided Emergency Use Authorizations (EUA) for 2 novel virus-neutralizing monoclonal antibody therapies, bamlanivimab and REGN-COV2 (casirivimab plus imdevimab), for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adolescents and adults in specified high-risk groups. This has challenged clinicians to determine the best approach to use of these products.MethodsA panel of experts in pediatric infectious diseases, pediatric infectious diseases pharmacy, pediatric intensive care medicine, and pediatric hematology from 29 geographically diverse North American institutions was convened. Through a series of teleconferences and web-based surveys, a guidance statement was developed and refined based on review of the best available evidence and expert opinion.ResultsThe course of COVID-19 in children and adolescents is typically mild and there is no high-quality evidence supporting any high-risk groups. There is no evidence for safety and efficacy of monoclonal antibody therapy for treatment of COVID-19 in children or adolescents, limited evidence of modest benefit in adults, and evidence for potential harm associated with infusion reactions or anaphylaxis.ConclusionsBased on evidence available as of December 20, 2020, the panel suggests against routine administration of monoclonal antibody therapy (bamlanivimab, or casirivimab and imdevimab), for treatment of COVID-19 in children or adolescents, including those designated by the FDA as at high risk of progression to hospitalization or severe disease. Clinicians and health systems choosing to use these agents on an individualized basis should consider risk factors supported by pediatric-specific evidence and ensure the implementation of a system for safe and timely administration that does not exacerbate existing healthcare disparities.

BackgroundAlthough coronavirus disease 2019 (COVID-19) is a mild infection in most children, a small proportion develop severe or critical illness. Data describing agents with potential antiviral activity continue to expand such that updated guidance is needed regarding use of these agents in children.MethodsA panel of pediatric infectious diseases physicians and pharmacists from 20 geographically diverse North American institutions was convened. Through a series of teleconferences and web-based surveys, a set of guidance statements was developed and refined based on review of the best available evidence and expert opinion.ResultsGiven the typically mild course of COVID-19 in children, supportive care alone is suggested for most cases. For children with severe illness, defined as a supplemental oxygen requirement without need for noninvasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO), remdesivir is suggested, preferably as part of a clinical trial if available. Remdesivir should also be considered for critically ill children requiring invasive or noninvasive mechanical ventilation or ECMO. A duration of 5 days is appropriate for most patients. The panel recommends against the use of hydroxychloroquine or lopinavir-ritonavir (or other protease inhibitors) for COVID-19 in children.ConclusionsAntiviral therapy for COVID-19 is not necessary for the great majority of pediatric patients. For children with severe or critical disease, this guidance offers an approach for decision-making regarding use of remdesivir.

BackgroundAlthough coronavirus disease 2019 (COVID-19) is mild in nearly all children, a small proportion of pediatric patients develop severe or critical illness. Guidance is therefore needed regarding use of agents with potential activity against severe acute respiratory syndrome coronavirus 2 in pediatrics.MethodsA panel of pediatric infectious diseases physicians and pharmacists from 18 geographically diverse North American institutions was convened. Through a series of teleconferences and web-based surveys, a set of guidance statements was developed and refined based on review of best available evidence and expert opinion.ResultsGiven the typically mild course of pediatric COVID-19, supportive care alone is suggested for the overwhelming majority of cases. The panel suggests a decision-making framework for antiviral therapy that weighs risks and benefits based on disease severity as indicated by respiratory support needs, with consideration on a case-by-case basis of potential pediatric risk factors for disease progression. If an antiviral is used, the panel suggests remdesivir as the preferred agent. Hydroxychloroquine could be considered for patients who are not candidates for remdesivir or when remdesivir is not available. Antivirals should preferably be used as part of a clinical trial if available.ConclusionsAntiviral therapy for COVID-19 is not necessary for the great majority of pediatric patients. For those rare cases of severe or critical disease, this guidance offers an approach for decision-making regarding antivirals, informed by available data. As evidence continues to evolve rapidly, the need for updates to the guidance is anticipated.

Background Inappropriate antimicrobial use (AU) is recognized as a leading cause of antimicrobial resistance. However, quantifying AU in hospitals is challenging due to variability in information systems. Point prevalence surveys (PPS) provide a means to quantify AU in a cross-sectional manner within and between institutions. The aim of the study was to describe and compare the prescription patterns of AU across pediatric hospitals in Canada using PPS. Methods Two PPS (November 2018 and February 2019) were conducted at each of the 15 Canadian pediatric hospitals. For each PPS, AU data were collected for all inpatients ≤ 18 years (excluded mental health and birthing units) on the survey date. Data, including admitting diagnosis, age, comorbidities, Infectious Diseases consult, admitting service, documented pathogen(s), and antimicrobial(s) prescribed, was collected and entered into a RedCap database. Results In total, we surveyed 3826 patient-days. The mean proportion of children receiving at least one antimicrobial was 35.2% [range 25.1% to 42.9%]. Of the 1951 antimicrobials prescribed, the most common were third-generation cephalosporins [3GC] (16%; 321), aminopenicillins (15%; 297), TMP-SMX (11%; 207), piperacillin–tazobactam (10%; 193) and first-generation cephalosporins (9%; 181). Overall, the frequency of carbapenems, quinolones and vancomycin use was 4% (79), 3% (65) and 8% (151), respectively. Of the antimicrobials used for targeted or empiric therapy (n = 1541), 373 (24.2%) were for pneumonia, 278 (18%) for intra-abdominal infections and 251 (16.3%) for fever without a source. For the treatment of community-acquired pneumonia (CAP) (n = 178), aminopenicillins and 3GC use was 31% and 37%, respectively. Conclusion Our study used a standardized approach to assess AU to obtain benchmarking data for Canadian pediatric hospitals. About one-third of children hospitalized in Canadian pediatric hospitals are prescribed at least one antimicrobial. Of patients on treatment for CAP, only 31% were prescribed aminopenicillins. More detailed analysis of the rationale for AU, and assessment of appropriateness is required to fully understand antimicrobial prescribing practices in pediatric hospitals and develop stewardship initiatives. Disclosures All authors: No reported disclosures. [ABSTRACT FROM AUTHOR]