Background
Starting in November 2020, the US Food and Drug Administration (FDA) has issued Emergency Use Authorizations (EUAs) for multiple novel virus-neutralizing monoclonal antibody therapies, including bamlanivimab monotherapy (now revoked), bamlanivimab and etesivimab, casirivimab and imdevimab (REGEN-COV), and sotrovimab, for treatment or postexposure prophylaxis of Coronavirus disease 2019 (COVID-19) in adolescents (≥12 years of age) and adults with certain high-risk conditions. Previous guidance is now updated based on new evidence and clinical experience.
Methods
A panel of experts in pediatric infectious diseases, pediatric infectious diseases pharmacotherapy, and pediatric critical care medicine from 18 geographically diverse US institutions was convened. Through a series of teleconferences and web-based surveys, a guidance statement was developed and refined based on a review of the best available evidence and expert opinion.
Results
The course of COVID-19 in children and adolescents is typically mild, though more severe disease is occasionally observed. Evidence supporting risk stratification is incomplete. Randomized controlled trials have demonstrated the benefit of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2)-specific monoclonal antibody therapies in adults, but data on safety and efficacy in children or adolescents are limited. Potential harms associated with infusion reactions or anaphylaxis are reportedly low in adults.
Conclusions
Based on evidence available as of August 31, 2021, the panel suggests a risk-based approach to administration of SARS-CoV-2 monoclonal antibody therapy. Therapy is suggested for the treatment of mild to moderate COVID-19 in adolescents (≥12 years of age) at the highest risk of progression to hospitalization or severe disease. Therapeutic decision-making about those at moderate risk of severe disease should be individualized. Use as postexposure prophylaxis could be considered for those at the highest risk who have a high-risk exposure but are not yet diagnosed with COVID-19. Clinicians and health systems should ensure safe and timely implementation of these therapeutics that does not exacerbate existing healthcare disparities.
Background
The epidemiology of orbital cellulitis likely has evolved due to the emergence of methicillin-resistant Staphylococcus aureus (MRSA) and the adoption of pneumococcal conjugate vaccination. In the absence of published guidelines, management is highly variable. We characterized epidemiology and management over an 11-year period.
Methods
A retrospective cohort study of children 0 to 21 years of age with orbital cellulitis +/− subperiosteal orbital abscess hospitalized at a large quaternary children’s hospital from January 2008 to June 2018. We reviewed charts for demographic characteristics, clinical features, management, and outcomes. Using multivariable logistic regression, we evaluated predictors of surgical intervention and assessed whether corticosteroid use or antibiotic duration was related to clinical outcomes.
Results
Among 220 patients, methicillin-susceptible S. aureus was the most common organism (26.3%), with MRSA found in only 5.0%. Rates of vancomycin use fluctuated annually from 40.9% to 84.6%. Surgery was performed in 39.5% of the patients. Corticosteroids, used in 70 patients (32.1%), were unrelated to treatment failure (n = 9), defined as persistent signs and symptoms or initial clinical improvement followed by worsening (P = .137). The median antibiotic duration was 17 days (interquartile range 14-26). After controlling for age, gender, proptosis, eye pain with movement, eyelid swelling, neutrophil count, and corticosteroid use, treatment failure was not significantly associated with receipt of ≥ 3 weeks of antibiotic therapy (8/84, 9.5%) compared with > 2 but < 3 weeks (0/51, 0.0%) or ≤ 2 weeks (1/85, 1.2%) (adjusted odds ratio = 5.83 for ≥ 3 vs ≤2 weeks; 95% confidence interval: 0.58, 59.0).
Conclusions
Although MRSA was rare, empiric vancomycin use was high. Treatment failure was uncommon in patients who received ≤ 2 weeks of therapy, suggesting that shorter durations are adequate in some patients.
Antimicrobial stewardship programs (ASPs) can be expanded to the outpatient setting to serve as a first line of defense against coronavirus disease 19 (COVID-19) hospitalizations and to reduce the burden on emergency departments and acute-care hospitals. Given the numerous emergency use authorizations of monoclonal antibodies and oral antivirals, ASPs possess the expertise and leadership to direct ambulatory COVID-19 initiatives and transform it into a predominantly outpatient illness. In this review, we summarize the critical role and benefits of an ASP-championed ambulatory COVID-19 therapeutics program.
Monoclonal antibodies for COVID-19 are authorized in high-risk patients aged ≥12 years, but evidence in pediatric patients is limited. In our cohort of 142 patients treated at seven pediatric hospitals between 12/1/20 and 7/31/21, 9% developed adverse events, 6% were admitted for COVID-19 within 30 days, and none received ventilatory support or died.
A 2-year-old boy was followed at a tertiary paediatric centre for a congenital lumbar ulcerated skin lesion. First-and secondtrimester ultrasounds were normal, while in the third trimester, aImage 1 Presentation at the first appointment (6-month-old).
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